BEUDAMED
    FDA Adverse Event Other Summary report: N

    KONICA MINOLTA AIR-SHIELDS JAUNDICE METER

    MDR report key: 726097 · Received June 6, 2006

    Report

    Report Number
    726097
    Event Type
    Other
    Date Received
    June 6, 2006
    Date of Event
    May 30, 2006
    Report Date
    June 6, 2006
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    LMX
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    NURSE TOOK A READING WITH THE JAUNDICE METER AND GOT A READING OF 7.6. SERUM THAT WAS DRAWN AND SENT AT THE SAME TIME WAS 12.7, WITH A DIFFERENCE OF 5.1 POINTS ON BABY'S BILIRUBIN LEVEL. ALL FOUR JAUNDICE METERS WERE PULLED BECAUSE THE DEPARTMENT WASN'T SURE WHICH UNIT HAD BEEN USED. CALIBRATION ON ALL FOUR METERS WAS DONE. THEY ALL CALIBRATED OUT OK. ALL FOUR UNITS ARE BEING SENT BACK TO THE MANUFACTURER FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KONICA MINOLTA AIR-SHIELDS JAUNDICE METER JAUNDICE METER LMX DRAEGER MEDICAL, INC. JM-103 *
    2 KONICA MINOLTA AIR-SHIELDS JAUNDICE METER JAUNDICE METER LMX DRAEGER MEDICAL, INC. JM-103 *
    3 KONICA MINOLTA AIR-SHIELDS JAUNDICE METER JAUNDICE METER LMX DRAEGER MEDICAL, INC. JM-103 *
    4 KONICA MINOLTA AIR-SHIELDS JAUNDICE METER JAUNDICE METER LMX DRAEGER MEDICAL, INC. JM-103 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *