Misinterpretation of Jaundice Meters Triggers a Recall
Draeger Medical Systems is recalling its Jaundice Meter JM-103 and JM-105 models after some users have misinterpreted display messages that have resulted in serious injuries, according to an FDA notice.
The Jaundice Meters are used to measure bilirubin in newborns. Specifically, the JM-103 model displays three blinking dashes (---) and the JM-105 meter displays dash-zero-dash (-0-) when the bilirubin level in the patient is higher than the maximum level of detection. Measurement of high bilirubin indicates a need for immediate medical evaluation. Some users have interpreted the two display messages as indicating a low or ...
Source: MDDI - June 25, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Regulatory and Compliance Source Type: news
Liver disease: Are you at risk? 11 symptoms of hepatitis to watch out for
LIVER disease can be caused by excess alcohol intake and it ’s a common condition in the UK. Hepatitis is a term used to describe inflammation of the liver, and while many people won’t realise they have it because it doesn’t usually cause symptoms, it can cause sudden jaundice and liver failure in some people. (Source: Daily Express - Health)
Source: Daily Express - Health - June 25, 2018 Category: Consumer Health News Source Type: news
Draeger Medical Systems, Inc. Jaundice Meter JM-103 and Jaundice Meter JM-105 Recalled Due to Misinterpretation of Display Messages for Out of Range Values https://go.usa.gov/xUqzz #medicaldevice #fda
Draeger Medical Systems, Inc. Jaundice Meter JM-103 and Jaundice Meter JM-105 Recalled Due to Misinterpretation of Display Messages for Out of Range Values https://go.usa.gov/xUqzz #medicaldevice #fda (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 22, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news
Mushroom poisoning mimicking painless progressive jaundice: a case report with review of the literature - Perisetti A, Raghavapuram S, Sheikh AB, Yendala R, Rahman R, Shanshal M, Thein KZ, Farooq A.
Mushroom poisoning is common in the United States. The severity of mushroom poisoning may vary, depending on the geographic location, the amount of toxin delivered, and the genetic characteristics of the mushroom. Though they could have varied presentatio... (Source: SafetyLit)
Source: SafetyLit - June 18, 2018 Category: International Medicine & Public Health Tags: Home and Consumer Product Safety Source Type: news
FDA issues select recall of Draeger Jaundice Meters
The FDA recently posted notice of a select recall of Draeger Medical Jaundice Meters over issues with users misinterpreting the display.
The recall affects all Draeger Medical’s Jaundice Meter JM-105 units, and has been labeled as a Class I recall, indicating the potential for serious injury or death.
The Draeger Jaundice Meter is designed for hospital use in the monitoring of newborn infants, according to an FDA notice.
The recall notice was posted due to users misinterpreting a blinking “-0-” as a zero measurement, and operating the device and delivering care based on that reading.
Draeger began notifying u...
Source: Mass Device - June 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Patient Monitoring Recalls Draeger Medical Source Type: news
Tennessee Is Just the Latest State to Report a Hepatitis A Outbreak. Here ’s What to Know
Tennessee has joined a growing number of states battling hepatitis A outbreaks, public health officials report.
The Nashville Metro Public Health Department (MPHD) announced that 14 cases of hepatitis A have been confirmed in the city since December 2017 —significantly more than the two cases it sees in an average year. MPHD is working with state public health officials to contain the outbreak, according to a statement, but the infection has already popped up in a number of nearby states, as well as some on the West Coast.
Here’s what to know hepatitis A and the outbreaks around the country.
What is hepatitis ...
Source: TIME: Health - May 30, 2018 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized healthytime Infectious Disease onetime Source Type: news
Jaundice Overview Video Jaundice Overview Video
Jaundice is a condition where the skin and eyes take on a yellowish color due to increased levels of bilirubin in the bloodstream. Find out more in this video.Osmosis (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 25, 2018 Category: Consumer Health News Tags: Med Students Commentary Source Type: news
Why Do Some Lizards Have Green Blood?
Scientists are trying to figure out how green-blooded lizards might benefit from the unusual pigment. The answer could provide new insights into human illnesses like jaundice and malaria. (Image credit: Courtesy of Christopher C. Austin/LSU) (Source: NPR Health and Science)
Source: NPR Health and Science - May 16, 2018 Category: Consumer Health News Authors: Nell Greenfieldboyce Source Type: news
FDA Panel Urges Rejection of Jaundice Drug for Newborns FDA Panel Urges Rejection of Jaundice Drug for Newborns
An FDA panel suggests further study of stannsoporfin as a hyperbilirubinemia treatment for newborns. The experimental drug has passed through several organizations since the late 1980s.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 5, 2018 Category: Consumer Health News Tags: Pediatrics News Source Type: news
FDA Advisory Panels Pan Neonatal Jaundice Drug
(MedPage Today) -- Vote tally: 3-21 against approval (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - May 4, 2018 Category: American Health Source Type: news
Mallinckrodt Reports on FDA Joint Advisory Committee Meeting for Stannsoporfin for the Treatment of Newborns at Risk of Developing Severe Jaundice
STAINES-UPON-THAMES, United Kingdom, May 3, 2018 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today expressed disappointment that, in a joint meeting, the U.S. Food and Drug Administration ' s... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 3, 2018 Category: Drugs & Pharmacology Source Type: news
FDA Staff: Neonatal Jaundice Drug Effective, But Safety Uncertain
(MedPage Today) -- Tin-based agent may have long-term neurotoxic effect (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - May 2, 2018 Category: American Health Source Type: news
Medical News Today: Diet for jaundice: What to eat for a healthy liver
A person ’s diet plays a major role in jaundice recovery and prevention. Learn about metabolism and what to eat for a healthy liver. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - March 20, 2018 Category: Consumer Health News Tags: Nutrition / Diet Source Type: news
Boston Sci Whets M & amp;A Appetite with EMcision Buy
Boston Scientific could be very busy with M&A this year. During the Marlborough, MA-based company’s most recent earnings call, CEO Michael Mahoney hinted at the possibility of potential acquisitions.
“We do have a pretty active M&A appetite,” Mahoney said, according to a transcript from Seeking Alpha. "So, I think you'll see us be active with tuck-in acquisitions to strengthen our category leadership strategy."
On Monday, Boston Scientific backed up its CEO’s words and revealed it would strengthen its endoscopy offerings with the acquisition of London – based EMcision, for an undisclosed sum.
With the EM...
Source: MDDI - March 5, 2018 Category: Medical Devices Authors: Omar Ford Tags: Medical Device Business Source Type: news
Mallinckrodt Receives FDA Acceptance of Stannsoporfin New Drug Application Filing
Action date set for August 22, 2018
STAINES-UPON-THAMES, United Kingdom, Feb. 23, 2018 -- (Healthcare Sales & Marketing Network) -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced the U.S. Food and Drug ... Biopharmaceuticals, FDA Mallinckrodt, stannsoporfin, hyperbilirubinemia, jaundice (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 23, 2018 Category: Pharmaceuticals Source Type: news
