BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA

    MDR report key: 2981373 · Received February 27, 2013

    Report

    Report Number
    1823260-2013-01202
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 5, 2013
    Report Date
    August 20, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT HER AVIVA METER SHOWS SIGNS OF AN ELECTRICAL SHORT. THE DISPLAY OF THE METER APPEARS BURNT, AND HAS A BLUISH-ORANGE BURN GOING FROM THE BOTTOM TO THE TOP OF THE SCREEN. CUSTOMER STATES THAT SHE NOTICED THE BURN THIS MORNING. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83956 ACCU-CHEK ® AVIVA BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1