MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. DRAGER JAUNDICE METER, MODEL JM-105; BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM

Model Number MU20105

Device Problems Image Display Error/Artifact (1304); Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Jaundice (2187)

Event Date 08/26/2018

Event Type  malfunction  

Event Description

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.

• Brand Name: DRAGER JAUNDICE METER, MODEL JM-105
• Type of Device: BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA 18969
• MDR Report Key: 7884759
• MDR Text Key: 120572810
• Report Number: 7884759
• Device Sequence Number: 1
• Product Code: MQM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/05/2018,08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MU20105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2 DA
• Patient Weight: 3