BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ADVANTAGE

    MDR report key: 2914388 · Received January 14, 2013

    Report

    Report Number
    1823260-2013-00284
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    March 19, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K032552
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT THE METER HAD A BLACK SPOT ON THE SCREEN THAT APPEARS TO BE CAUSED FROM BURNING. REPORTER ALSO ALLEGED THAT THE METER SHOWED SIGNS OF MELTING OR FLAMING. NO ACTIONS TAKEN BASED ON DEVICE. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20679 ACCU-CHEK ® ADVANTAGE BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1