BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA

    MDR report key: 3173637 · Received June 17, 2013

    Report

    Report Number
    1823260-2013-03660
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    CALLER REPORTED HIS AVIVA METER IS SHOWING SIGNS OF BURNING. CUSTOMER'S METER HAD A BROWN SPOT ON THE GLASS INSIDE OF IT. NO ADVERSE EVENT WAS REPORTED. METER NOT AVAILABLE FOR RETURN, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274308 ACCU-CHEK ® AVIVA BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1