BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2830389 · Received November 13, 2012

    Report

    Report Number
    1823260-2012-05724
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    September 28, 2012
    Report Date
    January 7, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES: 199 MG/DL (STRIP LOT 551640), 105 MG/DL AND 101 MG/DL (STRIP LOT 551600). RESULTS WERE OBTAINED USING DIFFERENT STRIP LOTS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND BOTH STRIP LOTS, 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 551640

    Patients

    Seq Age Sex Outcome Treatment
    1 074 YR UNSPECIFIED CHOLESTEROL MEDICATION| UNSPECIFIED BLOOD PRESSURE MEDICATION