BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 6060537 · Received October 27, 2016

    Report

    Report Number
    3011393376-2016-06964
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    September 30, 2016
    Report Date
    December 7, 2016
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LFR
    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 THE AVIVA EXPERT SYSTEM WITHIN 10 MINUTES: 3.7 MMOL/L, AND 9.0 MMOL/L. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712229 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIABETES CARE, INC. 496264

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR