BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1885263 · Received October 28, 2010

    Report

    Report Number
    1823260-2010-06409
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 12, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF "300S" MG/DL AND "100S" MG/DL WITHIN 1 MINUTE. 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 302687

    Patients

    Seq Age Sex Outcome Treatment
    1 069 YR LANTUS 1XDAY| CLONIDINE 2XDAY| MULTIVITAMIN 1XDAY| ACUPRIL| SYMLIN| METFORMIN 2XDAY| HUMALOG