BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA COMBO

    MDR report key: 3924810 · Received July 10, 2014

    Report

    Report Number
    1823260-2014-05070
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 13, 2014
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTED CONCERN WITH METER. PRELIMINARY EVALUATION OF THE METER ON (B)(6) 2014 FOUND A VERTICAL LINE RUNNING THROUGH THE MIDDLE OF THE METER DISPLAY; NO EVIDENCE OF PHYSICAL DAMAGE. NO ADVERSE EVENT REPORTED. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED METER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403111 ACCU-CHEK ® AVIVA COMBO BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown