BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1311208 · Received February 11, 2009

    Report

    Report Number
    1823260-2009-01102
    Event Type
    Injury
    Date Received
    February 11, 2009
    Date of Event
    December 1, 2008
    Report Date
    February 11, 2009
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED 2 INCIDENTS IN WHICH THE AVIVA SYSTEM GAVE A BLOOD GLUCOSE RESULT OF 120 MG/DL AT A TIME WHEN SHE WAS SYMPTOMATIC OF HYPOGLYCEMIA, REQUIRED TREATMENT BY LAYPERSON IN EACH INSTANCE. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM AND A REPLACEMENT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention NOVOPEN 35 UNITS 3-4/DAY - "A FEW YRS"| LANTUS 50 UNITS/DAY - "A FEW YRS"| LANTUS 20 UNITS/DAY - "A FEW YRS"