BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1780203 · Received September 21, 2007

    Report

    Report Number
    1823260-2007-08268
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    July 19, 2007
    Report Date
    September 21, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RPTR ALLEGED BLOOD GLUCOSE RESULTS OF 418 MG/DL ON THE ADVANTAGE SYSTEM COMPARED TO 112 MG/DL WHEN TESTING WAS PERFORMED BACK-TO-BACK ON A PROFESSIONAL METER. RPTR ALSO ALLEGED BLOOD GLUCOSE RESULTS OF 428 MG/DL ON THE ADVANTAGE SYSTEM COMPARED TO 128 MG/DL WHEN TESTING WAS PERFORMED BACK-TO-BACK ON A PROFESSIONAL METER. THE RPTR STATED THE CUSTOMER HAD NO SYMPTOMS AND NO TREATMENT OR ACTION WAS TAKEN BASED ON RESULTS. NO SERIOUS ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. THE SUSPECT PRODUCT IS UNAVAILABLE FOR RETURN; REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA