BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1923895 · Received December 14, 2010

    Report

    Report Number
    1823260-2010-07409
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    December 2, 2010
    Report Date
    February 8, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED ADVANTAGE BLOOD GLUCOSE RESULTS: 4:11 PM 288 MG/DL 4:00 PM 150 MG/DL 3:57 PM 422 MG/DL REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT 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 551186

    Patients

    Seq Age Sex Outcome Treatment
    1 054 YR METFORMIN| INSULIN 70/30, UNKNOWN BRAND