BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 840669 · Received February 27, 2007

    Report

    Report Number
    1823260-2007-01672
    Event Type
    Malfunction
    Date Received
    February 27, 2007
    Date of Event
    February 8, 2007
    Report Date
    February 27, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE IS COMFORT CURVE TEST STRIPS, LOT UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 322MG/DL AND 60MG/DL ON THE ADVANTAGE TEST SYSTEM WITHIN 10 MINUTES. NO ACTION WAS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. CALLER STATES THAT 2 VIALS WERE USED, IT WAS NOT PROVIDED WHICH VIAL PRODUCED SPECIFIC RESULT. FURTHER, ONE STRIP VIAL WAS NOT AVAILABLE AND NO INFO ABOUT VIAL WAS OBTAINED. INFO NOT PROVIDED FOR WHERE COMPARISON OCCURRED. ADVANTAGE TEST SYSTEM 1; METER, STRIP LOT 549527, EXP 2/29/2008, CATALOG 2030381. ADVANTAGE TEST SYSTEM 2: METER, STRIP LOT UNK, EXP UNK, CATALOG UNK.

    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 * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR PROTONIX RECENT PILL 1X DAY, 40MG| METFORMIN 500MG/2XDAY