BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 7443109 · Received April 19, 2018

    Report

    Report Number
    3011393376-2018-01762
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    April 16, 2018
    Report Date
    August 8, 2018
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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 A AVIVA METER, WITHIN 10 MINUTES: HI (>33.33 MMOL/L), HI (>33.33 MMOL/L), 7.3 MMOL/L, HI (>33.33 MMOL/L), AND 18.3 MMOL/L. NO ADVERSE EVENT REPORTED. RETURN OF THE SUSPECT DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286909 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 497360

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR