BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2832877 · Received November 14, 2012

    Report

    Report Number
    1823260-2012-05762
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 13, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR THE ADVANTAGE SYSTEM. (B)(6).

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT METERS, WITHIN 10 MINUTES: 381 MG/DL (ADVANTAGE) AND 81 MG/DL (COMPACT PLUS). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, 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 551782

    Patients

    Seq Age Sex Outcome Treatment
    1 074 YR FENOFIBRATE| ZETIA| METOPROLOL| ELECTRIC WHEELCHAIR| ISOSORB| PAROXETINE| AMITRIPTYLINE| GLYBURIDE