Jaundice Meters Recalled After Misinterpretations Result In Severe Injuries

Federal health officials have announced a Class I recall of certain jaundice meters, following reports that suggest the digital display readings may be misinterpreted, resulting in delayed in treatment, which may increase the risk of serious and potentially life threatening injuries for infants. 

A Draeger Medical Systems jaundice meter recall was announced by FDA on June 22, after receiving reports of users misinterpreting bilirubin levels in patients that could delay or cause a failure to treat hazards.

The devices being recalled are non-invasive transcutaneous bilrubinmoters, which measure yellowness of subcutaneous tissue in newborn infants. The devices are intended to be used in hospitals or doctor’s offices to provide obtain a digital measurement of bilirubin to determine what type of treatment, if any, is required.

Jaundice is a common condition for preterm infants that causes a yellowing of the skin or whites of the eyes, typically arising from excess pigment bilirubin. The condition typically occurs due to an obstruction of the bile duct, liver disease or an excessive breakdown of red blood cells. The condition is treatable in most scenarios with light therapy or intravenous fluids and medication.

According to the recall, the devices display a digital message on the monitor that could be easily misinterpreted by the end user. 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.

The FDA has received reports of users interpreting the two display messages as indicating “low” or “zero” values instead of high levels requiring medical attention and additional diagnosis. In this event, the misinterpretation of a high bilirubin level could result in the failure to treat or delay treatment that could cause serious adverse health consequences such as acute and/or chronic brain damage or death.

The recalled devices were manufactured by Draeger Medical Systems, Inc. of Telford, Pennsylvania and include Jaundice Meters models JM-103: MU20606 and Jaundice Meter JM-105: MU20105 with product codes MQM. The JM-103 model was manufactured from June 2008 through August 2017 and distributed for sale throughout the U.S. from July 2008 to September 2017. The JM-105 model was manufactured from September 2013 through April 2018 and distributed for sale throughout the U.S. from October 2013 to April 2018.

FDA officials have classified this recall as Class I, which is reserved for the most serious types of recalls, where there is a reasonable probability that the use of the device will cause serious injury or death.

Draeger Medical has issued an Urgent Medical Device Safety Notice to customers informing them of the known misinterpretation events and instructions on how to label the devices and provide proper training to hospital personnel. Customers will be receiving a separate communication from the manufacturer with information pertaining to new software available.