BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2173432 · Received July 23, 2011

    Report

    Report Number
    1823260-2011-03923
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 21, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 362 MG/DL AND 134 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM WHILE USING COMFORT CURVE TEST STRIPS. 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 551511

    Patients

    Seq Age Sex Outcome Treatment
    1 084 YR "70/30" INSULIN AM/PM| UNK HIGH BLOOD PRESSURE MED| UNKNOWN STEROIDS