BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOCUE GLUCOSE 201 MICROCUVETTE

    MDR report key: 3608638 · Received November 21, 2013

    Report

    Report Number
    3003044483-2013-00026
    Event Type
    Other
    Date Received
    November 21, 2013
    Date of Event
    October 25, 2013
    Report Date
    October 25, 2013
    Manufacturer
    HEMOCUE AB
    Product Code
    LFR
    PMA / PMN Number
    K20935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN AN INTERNAL INSPECTION, A PRODUCTION RELATED PROBLEM WAS IDENTIFIED DAMAGING THE OUTER PACKAGING MATERIAL OF MICROCUVETTES (POUCH). THE PROBABILITY OF DAMAGED POUCHES REACHING CUSTOMERS IS HIGHLY UNLIKELY BASED ON VISUAL INSPECTION AND REMOVAL OF DAMAGED POUCHES. HOWEVER, DAMAGED POUCHES HAVE REDUCED RESISTANCE TO MOISTURE WHICH AFFECTS THE PERFORMANCE OF THE MICROCUVETTES.

    Description of Event or Problem · 1

    A PRODUCTION RELATED PROBLEM WAS IDENTIFIED POSSIBLY DAMAGING THE OUTER PACKAGING MATERIAL OF MICROCUVETTES (POUCH). DAMAGED POUCHES CAN ALLOW ENTERING OF MOISTURE AND NEGATIVELY AFFECTING THE PERFORMANCE OF THE MICROCUVETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606792 HEMOCUE GLUCOSE 201 MICROCUVETTE LFR GLUCOSE TEST SYSTEM LFR HEMOCUE AB

    Patients

    Seq Age Sex Outcome Treatment
    1