BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA COMBO

    MDR report key: 4844283 · Received June 15, 2015

    Report

    Report Number
    1823260-2015-03625
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    January 13, 2015
    Report Date
    August 1, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    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)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. THIS REPORT WAS SUBMITTED USING THE WRONG MANUFACTURER REPORT NUMBER. PLEASE SEE CASE WITH PATIENT IDENTIFIER (B)(6) AND MANUFACTURER REPORT NUMBER 3011393376-2015-01129 FOR THE CORRECT REPORT. NO PRODUCT WILL BE RETURNED ON THIS CASE.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THAT THE METER HAS A BLACK LINE DOWN THE MIDDLE OF THE SCREEN, AND THE DISPLAY IS GENERALLY DEFECTIVE. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387978 ACCU-CHEK ® AVIVA COMBO BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIABETES CARE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male