BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA COMBO

    MDR report key: 3890707 · Received June 24, 2014

    Report

    Report Number
    1823260-2014-04623
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    April 1, 2014
    Report Date
    July 25, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    REPORTER STATED THERE IS A BLACK LINE ACROSS THE DISPLAY OF THE BLOOD GLUCOSE MONITOR. THE CUSTOMER'S MOTHER ORIGINALLY STATED THE MEASUREMENT RESULTS WERE NOT AFFECTED; HOWEVER, DURING THE EVALUATION, IT WAS FOUND THE LINE DISTORTS THE RESULTS. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368280 ACCU-CHEK ® AVIVA COMBO BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male