BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 6044978 · Received October 20, 2016

    Report

    Report Number
    3011393376-2016-06769
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 28, 2016
    Report Date
    December 5, 2016
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THIS CASE, WITH PATIENT IDENTIFIER (B)(6) (AVIVA SYSTEM), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6) (MOBILE SYSTEM).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT METERS, WITHIN 10 MINUTES: 418 MG/DL (AVIVA METER) AND 156 MG/DL (MOBILE METER). NO ADVERSE EVENT REPORTED. THE TEST STRIP LOT NUMBER FOR THE MOBILE METER WAS NOT PROVIDED. RETURN OF THE SUSPECT DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695100 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIABETES CARE, INC. 496153

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR