BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2841094 · Received November 20, 2012

    Report

    Report Number
    1823260-2012-05918
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 29, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. MEDWATCH WITH (B)(6) IS FOR AVIVA COMBO SYSTEM, MEDWATCH WITH (B)(6) IS FOR AVIVA SYSTEM. STRIPS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 170 MG/DL ON AVIVA COMBO SYSTEM, 70 MG/DL ON AVIVA SYSTEM WITHIN 10 MINUTES. REPORTED A SECOND, SEPARATE COMPARISON OF BLOOD GLUCOSE RESULTS OF 168 MG/DL ON AVIVA COMBO SYSTEM, 80 MG/DL ON AVIVA SYSTEM WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. STRIPS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 490625

    Patients

    Seq Age Sex Outcome Treatment
    1