BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1052348 · Received May 6, 2008

    Report

    Report Number
    1823260-2008-03798
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    April 17, 2008
    Report Date
    May 6, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INCIDENT OF HYPOGLYCEMIA A WEEK EARLIER REQUIRING PROFESSIONAL MEDICAL TREATMENT. IN THAT INCIDENT, CUSTOMER'S SYMPTOMS AND TREATMENT WERE CONSISTENT WITH DEVICE RESULTS. CUSTOMER REPORTED ANOTHER INCIDENT, METER RESULTS OF 185 MG/DL AND 83 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. CUSTOMER REPORTED SYMPTOMS OF HYPOGLYCEMIA, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED IN THIS INCIDENT. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE - LFR LFR ROCHE DIAGNOSTICS 550051

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR HUMULIN DOSAGE UNK