BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2254188 · Received September 19, 2011

    Report

    Report Number
    1823260-2011-04956
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 17, 2011
    Report Date
    September 19, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS HAVING LOW BLOOD GLUCOSE SYMPTOMS WITH RESULT OF 95 MG/DL OBTAINED ON THE AVIVA SYSTEM. WHILE ATTEMPTING TO TREAT HIS LOW BLOOD GLUCOSE SYMPTOMS, CUSTOMER PASSED OUT. APPROXIMATELY 40 MINUTES LATER A FRIEND FOUND THE CUSTOMER; CUSTOMER TESTED 18 MG/DL AND PARAMEDICS WERE CALLED. CUSTOMER TESTED 31 MG/DL ON PARAMEDIC'S METER WITHIN 10 MINUTES OF RESULT OF 18 MG/DL. CUSTOMER WAS TREATED WITH A GLUCOSE IV AND CUSTOMER AWOKE WITHIN 6 MINUTES. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR NOVOLOG| LANTUS