BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAEGER JAUNDICE METER JM-105

    MDR report key: 5952373 · Received September 13, 2016

    Report

    Report Number
    MW5064767
    Event Type
    Injury
    Date Received
    September 13, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 12, 2016
    Manufacturer
    DRAEGER, INC.
    Product Code
    MQM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "CRITICAL" TRANSCUTANEOUS BILLRUBIN LEVEL ON THIS DEVICE (GREATER THAN 340 UMOL/L OR GREATER THAN 20 MG/DL) REGISTERS AS FLASHING "- 0 -" WITH UNITS DISPLAYED BELOW (EITHER MG/DL OR UMOL/L). ON MORE THAN ONE OCCASION NURSES HAVE TAKEN THIS TO LITERALLY MEAN "0" AND HAVE NOT ACTED APPROPRIATELY (WHICH IS TO EITHER DRAW A SERUM BILIRUBIN OR AT LEAST NOTIFY THE PHYSICIAN). THIS HAS OCCURRED IN SPITE OF FAIRLY INTENSIVE NURSING TRAINING IN DEVICE USE. TO AVOID MISINTERPRETATION IT IS SUGGESTED THAT SOFTWARE BE MODIFIED SO THAT CRITICAL VALUES ARE DISPLAYED AS "HI", "- ! -" OR SIMILAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597211 DRAEGER JAUNDICE METER JM-105 JM-105 JAUNDICE METER MQM DRAEGER, INC. JM-105

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention