BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1963096 · Received January 18, 2011

    Report

    Report Number
    1823260-2011-00273
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA BLOOD GLUCOSE RESULTS OF 185 MG/DL AND 73 MG/DL WITHIN 10 MINUTES. REPORTED A SECOND, SEPARATE COMPARISON OF BLOOD GLUCOSE RESULTS OF 106 MG/DL, 280 MG/DL, AND 178 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 303020

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR ONGLYZA 1XDAY| PREDNISONE| HUMALOG