BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1123871 · Received August 15, 2008

    Report

    Report Number
    1823260-2008-06231
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED BLOOD GLUCOSE RESULTS OF 107 MG/DL ON THE INFORM SYSTEM AND A 16 MG/DL LAB VALUE WITHIN 10 MINUTES; 79 MG/DL ON THE INFORM SYSTEM AND A 30 MG/DL LAB VALUE WITHIN 10 MINUTES. CUSTOMER REPORTED NO SYMPTOMS OR TREATMENT. NO ADVERSE EVENT REPORTED. 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 TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550614

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ASCORBIC ACID 66MG/KG BODY WE