BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1920016 · Received December 10, 2010

    Report

    Report Number
    1823260-2010-07360
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 27, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED ADVANTAGE SYSTEM BLOOD GLUCOSE RESULTS OF 326 MG/DL AND AVIVA SYSTEM RESULT OF 150 MG/DL WITHIN 10 MINUTES. REPORTED FROM ANOTHER DAY ADVANTAGE SYSTEM BLOOD GLUCOSE RESULTS OF 317 MG/DL AND AVIVA SYSTEM RESULT OF 101 MG/DL WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 302006

    Patients

    Seq Age Sex Outcome Treatment
    1 054 YR ACTOS 1XDAY| LANTUS 1XDAY