BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA

    MDR report key: 1897004 · Received November 11, 2010

    Report

    Report Number
    1823260-2010-06700
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 11, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED HE ATTEMPTED TO TEST TWICE ON THE AVIVA SYSTEM BUT ONLY GOT ERROR MESSAGES WHILE FEELING DIZZY AND STAGGERING SO THAT HE COULD BARELY WALK. REPORTER STATED THAT HIS WIFE HAD TO TREAT HIM WITH JUICE. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. REPORTER STATED THAT HE WAS TESTING ON STRIPS STORED OUTSIDE OF THE VIAL WHICH IS NOT CORRECT PER LABELING. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN