BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 6200057 · Received December 22, 2016

    Report

    Report Number
    3011393376-2016-07981
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 4, 2016
    Report Date
    July 24, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ERRORS THAT OCCURRED IN THE SUBMISSION OF MDRS FOR INCORRECT MANUFACTURER NAME AND/OR ADDRESS. A NON-CONFORMANCE REPORT (NCR) ¿ 16847 TO IMPLEMENT CORRECTIVE ACTIONS WAS OPENED ON JANUARY 29, 2025. DEVICE PERFORMANCE AND/OR RISK PROFILE ARE NOT IMPACTED.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. 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

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA INSIGHT SYSTEM WITHIN 10 MINUTES: 11.4 MMOL/L AND 3.9 MMOL/L. NO ADVERSE EVENT REPORTED. ALLEGED TEST STRIPS HAVE BEEN DISCARDED; METER WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851131 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female