BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 4260974 · Received November 19, 2014

    Report

    Report Number
    1823260-2014-09008
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Date of Event
    October 24, 2014
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    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 · 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 RESULTS OF 2.9 MMOL/L, 31.3 MMOL/L, AND 3.8 MMOL/L WITHIN 8 MINUTES ON THE AVIVA EXPERT SYSTEM. PRIOR TO THESE RESULTS, HE TESTED, RECEIVED A RESULT OF 3.1 MMOL/L, AND THEN ATE TWO "PLATES" OF DEXTROSE AND 4 SLICES OF TOAST. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750249 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 493577

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male