BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2070936 · Received April 27, 2011

    Report

    Report Number
    1823260-2011-02283
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 22, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE ADVANTAGE SYSTEM (LOT NUMBER 551403, EXPIRATION DATE 11/30/2011). (B)(4). DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE ADVANTAGE SYSTEM (LOT NUMBER 551403, EXPIRATION DATE 11/30/2011). (B)(4).

    Description of Event or Problem · 1

    CUSTOMER RECEIVED RESULTS OF 55 MG/DL AND 56 MG/DL ON THE COMPACT PLUS SYSTEM AND RESULT OF 106 MG/DL ON THE ADVANTAGE SYSTEM WHILE USING COMFORT CURVE TEST STRIPS. THE RESULTS WERE OBTAINED WITHIN 10 MINUTES OF EACH OTHER. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 ROCHE DIAGNOSTICS NA 551403

    Patients

    Seq Age Sex Outcome Treatment
    1 036 YR