BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 841809 · Received February 16, 2007

    Report

    Report Number
    1823260-2007-01392
    Event Type
    Malfunction
    Date Received
    February 16, 2007
    Date of Event
    January 29, 2007
    Report Date
    February 16, 2007
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    KO10362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT PRODUCE IS COMFORT CURVE TEST STRIPS, LOT#549423, EXP DATE# 01/31/2008, CAT# 2030365.

    Description of Event or Problem · 1

    REPORTER TESTING ON ACCU-CHEK INFORM SYSTEM (INFORM METER, COMFORT CURVE TEST STRIPS LOT # 549423, EXP DATE# 01/31/2008). REPORTER STATES, SHE TESTED PT WITH BACK TO BACK RESULTS OF 20MG/DL AND 30MG/DL WITHIN MINUTES OF THE SAME METER. THEN A LAB WAS SENT WITH A RESULT OF 120MG/DL. PT WAS TREATED WITH D50 BASED ON METER RESULT. PT IS DOING FINE, NO MEDICATIONS WERE GIVEN. REPORTER STATES CONTROLS WERE RAN EARLIER AND PASSED. ACTUAL NUMBERS WERE NOT PROVIDED. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT, AND A 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 CORP. * 549423

    Patients

    Seq Age Sex Outcome Treatment
    1 NA