BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1860012 · Received October 7, 2010

    Report

    Report Number
    1823260-2010-06008
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER REPORTED HE WAS FEELING SHAKY AND SWEATY, AND OBTAINED A BLOOD GLUCOSE RESULT OF 120 MG/DL. AN AMBULANCE WAS CALLED FOR MEDICAL ASSISTANCE AND ABOUT 30 MINUTES LATER A PROFESSIONAL BLOOD GLUCOSE RESULT OF 64 MG/DL WAS OBTAINED. THE CUSTOMER WAS UNRESPONSIVE AND WAS TREATED WITH AN IV OF GLUCOSE, AND TRANSPORTED TO THE HOSPITAL, WHERE HE REMAINED HOSPITALIZED FOR A WEEK. THERE WAS NO DELAY IN SEEKING ASSISTANCE BASED UPON THE READING OF 120 MG/DL. THERE IS NO INDICATION OF ANY ACTION/INACTION BASED UPON RESULTS EARLIER THAT DAY, OR THE RESULTS PROVIDED ABOVE. 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 551204

    Patients

    Seq Age Sex Outcome Treatment
    1 083 YR