BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 6056866 · Received October 26, 2016

    Report

    Report Number
    3011393376-2016-06895
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    October 8, 2016
    Report Date
    December 12, 2016
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE, WITH PATIENT IDENTIFIER (B)(6) (SYSTEM 1), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6) (SYSTEM 2).

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE CUSTOMER RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT AVIVA METERS, WITHIN 10 MINUTES: "HI" MG/DL (SYSTEM 1) AND 153 MG/DL (SYSTEM 2). ON (B)(6) 2016, THE CUSTOMER RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT AVIVA METERS, WITHIN 10 MINUTES: 58 MG/DL (SYSTEM 1) AND 159 MG/DL (SYSTEM 2). THE "HI" MG/DL RESULT, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL. NO ADVERSE EVENT REPORTED. THE TEST STRIP LOT NUMBER FOR SYSTEM 2 WAS NOT PROVIDED. RETURN OF THE SUSPECT DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707660 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIABETES CARE, INC. 495846

    Patients

    Seq Age Sex Outcome Treatment
    1 NOVOLIN INSULIN