DRAGER JAUNDICE METER, MODEL JM-105 MU20105

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-18 for DRAGER JAUNDICE METER, MODEL JM-105 MU20105 manufactured by Draeger Medical Systems, Inc..

Event Text Entries

[120572810] Old for tp earlier this year, a recall notice was sent out for the draeger jm-103 and jm-105 jaundice meters for the reason that, "users have misinterpreted display messages that have resulted in serious injuries. Specifically, the jm-103 meter 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 (>340? Mol or 20mg/dl). 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, treatment may be delayed or not offered, which could lead to brain damage and possibly death in some newborns/infants. The out of range display is visible; however, the interpretation of the reading is not intuitive or clear. Uncertainty about the out of range indication on the jaundice meter could cause a delay of treatment in a patient with hyperbilirubinemia. " draeger provided labels to be applied to the meter to remind the user of the meaning of the displays. Despite our hospital having placed those labels on our machines, we experienced misinterpretation by multiple nurses and nas of the "0" when using the jm-105 and it was interpreted as a malfunction when the display on the jm-103 read "---". We feel the displays need to be redesigned using something other than 0 or dashes to indicate the bilirubin level is too high.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7884759
• MDR Report Key: 7884759
• Date Received: 2018-09-18
• Date of Report: 2018-08-31
• Date of Event: 2018-08-26
• Report Date: 2018-09-05
• Date Reported to FDA: 2018-09-05
• Date Reported to Mfgr: 2018-09-18
• Date Added to Maude: 2018-09-18
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DRAGER JAUNDICE METER, MODEL JM-105
• Generic Name: BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
• Product Code: MQM
• Date Received: 2018-09-18
• Model Number: MU20105
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DRAEGER MEDICAL SYSTEMS, INC.
• Manufacturer Address: 3135 QUARRY ROAD TELFORD PA 18969 US 18969

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-09-18