BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFOR CURVE TEST STRIPS

    MDR report key: 1193490 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07430
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 24, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 316 MG/DL, 129 MG/DL AND 108 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINS ON THE ADVANTAGE SYSTEM. REPORTER ALLEGED, AT ANOTHER TIME, SHE OBTAINED DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 502 MG/DL, 180 MG/DL AND 178 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINS ON THE ADVANTAGE SYSTEM. REPORTER INDICATED THAT SHE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIMES OF TESTING. NO ACTIONS WERE REPORTEDLY TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFOR CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS- LFR LFR ROCHE DIAGNOSTICS 550676

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR LANTUS- 6 YEARS 16 UNITS DAILY| HUMALOG- 6 YEARS 0-4 UNITS AS NEEDED