BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1172514 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07042
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED BLOOD GLUCOSE RESULTS OF 527 MG/DL AND 168 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. CUSTOMER REPORTED NO SYMPTOMS OF HYPERGLYCEMIA, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. STRIPS NOT AVAILABLE FOR RETURN, REPLACEMENT SYSTEM 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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR METOPROLOL 25MG/DAY| HUMALOG SLIDING SCALE - 6-7 YEARS| LANTUS 26 UNITS/DAY - 6-7 YEARS| COZAAR - 50 MG/DAY