BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 935299 · Received October 26, 2007

    Report

    Report Number
    1823260-2007-09374
    Event Type
    Injury
    Date Received
    October 26, 2007
    Date of Event
    October 4, 2007
    Report Date
    October 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER IS CALLING TO REPORT THAT A PT WAS TESTED WITH A RESULT OF 118MG/DL ON THE ACCU-CHEK INFORM METER IN COMPARISON TO A 37MG/DL LAB RESULT. THE RESULTS WERE OBTAINED WITHIN 10 MINUTES. THE CALLER REPORTS THAT THE PT WAS TREATED WITH OJ IF HE WAS CONSCIOUS OR D50 IF HE WAS UNCONSCIOUS. THE PT RECEIVED A DELAY IN TREATMENT. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    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 CORP. 549916

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR