BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1181955 · Received September 22, 2008

    Report

    Report Number
    1823260-2008-07078
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 56 MG/DL, 158 MG/DL, 171 MG/DL, 132 MG/DL, AND 137 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. REPORTER INDICATED THAT SHE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. REPORTER STATED SHE DID NOT TAKE HER INSULIN AS NORMAL BECAUSE OF THE READINGS OBTAINED. NO OTHER 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 CORP. 550636

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HUMULIN - 2 MONTHS - 24 UNITS| LANTUS - 2 MONTHS - 30 UNITS DAILY