BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1150927 · Received September 3, 2008

    Report

    Report Number
    1823260-2008-06613
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 96 MG/DL, 97 MG/DL AND 257 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. REPORTER INDICATED THAT HE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTED 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 COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550537

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR ASPIRIN 350MG DAILY| NEURONTIN 300MG 3 TIMES DAILY| LIPITOR 40MG DAILY| PLAVIX 75MG DAILY| AMARYL 0.5MG DAILY| ATENOLOL 12.5MG DAILY| PREVACID 30MG DAILY| ISOSORBIDE 30MG DAILY