BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE MICRO-DRAW TEST STRIPS

    MDR report key: 1118811 · Received August 14, 2008

    Report

    Report Number
    1832816-2008-00025
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    PARLEX (EUROPE), LTD.
    Product Code
    NBW
    PMA / PMN Number
    K031388
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL PRODUCT WAS NOT RETURNED FOR TESTING. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE TESTED, AND PERFORMED TO SPECIFICATION.

    Description of Event or Problem · 1

    CALLER INDICATED THE ADVANCE METER WAS READING HIGH. CAREGIVER TESTED PT AND REC'D 105 AND 117. PATIENT WAS NOT DOING WELL AND WAS GIVEN A MINT. WAS NOT ACTING NORMALLY, PARAMEDICS WERE CALLED, AND TOOK READING ON A DIFFERENT MONITOR AND BLOOD SUGAR WAS 24. CAREGIVER STATES THAT THE PATIENT WAS GIVEN INSULIN AND SHE STARTED TO DO BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE MICRO-DRAW TEST STRIPS BLOOD GLUCOSE TEST STRIP NBW PARLEX (EUROPE), LTD. 410050 03268A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention