BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA COMBO

    MDR report key: 3895041 · Received June 25, 2014

    Report

    Report Number
    1823260-2014-04670
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 2, 2014
    Report Date
    July 31, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(4).

    Description of Event or Problem · 1

    CALLER REPORTED THERE IS A THIN VERTICAL BLACK LINE IN THE MIDDLE OF THE DISPLAY OF THE METER. CALLER STATED PATIENT HAD AN ACCIDENT AND SINCE THEN THE VERTICAL LINE IS DISPLAYED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED METER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370918 ACCU-CHEK ® AVIVA COMBO BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male