BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 5216801 · Received November 11, 2015

    Report

    Report Number
    3011393376-2015-05071
    Event Type
    Malfunction
    Date Received
    November 11, 2015
    Date of Event
    October 26, 2015
    Report Date
    July 25, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LFR
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA EXPERT SYSTEM WITHIN 10 MINUTES: 17.2 MMOL/L HI (> 33.38 MMOL/L), 22 MMOL/L, 8.5 MMOL/L AND 7.2 MMOL/L. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747005 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIABETES CARE, INC. NA 495637

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female