BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1941941 · Received December 30, 2010

    Report

    Report Number
    1823260-2010-07748
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 23, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 551331, EXPIRATION DATE 07/31/2011). (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF HI (GREATER THEN 600 MG/DL) ON ADVANTAGE SYSTEM 1 AND 152 MG/DL ON ADVANTAGE SYSTEM 2 WITHIN 10 MINUTES. COMFORT CURVE TEST STRIPS WERE USED. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT 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 ROCHE DIAGNOSTICS NA 551331

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR SIMVASTATIN| OMEPRAZOLE| CITALOPRAM| ASPIRIN| METOPROLOL| TOLTERODINE| NOVOLIN 70/30| LISINOPRIL