These devices, manufactured by Draeger Medical Systems, are being recalled because some users have misinterpreted display messages. The JM-103 meter (pictured on the left) displays three blinking dashes (---) and the JM-105 meter (pictured on the right) displays dash-zero-dash (-0-) when the bilirubin level in the patient is higher than the maximum level of detection. The problem, according to FDA, is that some users have interpreted the two display messages as indicating a low or zero value instead of high bilirubin levels.FDA
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 zero value instead of high bilirubin levels. When this happens, FDA said, treatment may be delayed or not offered, which could lead to brain damage and possibly death in some babies.
The out of range display is visible; however, the interpretation of the reading is not intuitive or clear, FDA said.
The recall includes 2,449 JM-103 models manufactured between June 2008 and August 2017 and distributed between July 2008 and September 2017; and 2,063 JM-105 models manufactured between September 2013 and April 2018 and distributed between October 2013 and April 2018.
FDA noted that the Jaundice Meters are intended for use in hospitals or doctors' offices under a physician's supervision or at their direction to assist clinicians in monitoring newborn infants. The device is not intended as a standalone screening device for diagnosis of hyperbilirubinemia, the agency said. It is used as a screening device along with other clinical assessments and laboratory measurements.
The JM-105 meter is a modification of the JM-103 meter. The basic functionality, including the measuring probe, hardware, and software used to process the measurements are identical to the earlier model. The display of the later model includes a larger screen and touchscreen, and data storage and transmission functionality.