BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1971840 · Received January 27, 2011

    Report

    Report Number
    1823260-2011-00489
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 497 MG/DL AND 101 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM USING COMFORT CURVE TEST STRIPS. 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 DEVICE LFR ROCHE DIAGNOSTICS NA 551264

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR HUMULIN R| CPAP MACHINE| HUMULIN N| BLOOD PRESSURE MONITOR