BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1002105 · Received February 20, 2008

    Report

    Report Number
    1823260-2008-01726
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 12, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE RESULT OF 375 MG/DL BACK TO BACK WITH A RESULT OF 160 MG/DL ON THE AVIVA SYSTEM, WHEN TESTING WAS PERFORMED LESS THAN 10 MINS APART. REPORTER INDICATED THAT SHE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 300862

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HUMULIN N - TIME UNK 70 UNITS NIGHTLY| HUMULIN R - TIME UNK 50 UNITS NIGHTLY| NOVOLIN 70/30 - NO LONGER ON 80 UNITS DAILY| NOVOLIN 70/30 1 WEEK 115 UNITS DAILY