BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1123877 · Received August 15, 2008

    Report

    Report Number
    1823260-2008-06241
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED BLOOD GLUCOSE RESULTS OF HI, WHICH ON THE AVIVA SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL, AND 97 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. CUSTOMER REPORTED NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, 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 301241

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR HUMALOG SLIDING SCALE - 1 MONTH| LANTUS 18 UNITS/DAY - 1 MONTH