BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1053191 · Received May 27, 2008

    Report

    Report Number
    1823260-2008-04329
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 514 MG/DL BACK TO BACK WITH A RESULT OF 123 MG/DL ON THE AVIVA SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER INDICATED THAT SHE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTEDLY 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 300983

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR NOVOLOG LESS THAN 1 YEAR SLIDING SCALE| LANTUS LESS THAN 1 YEAR 32 UNITS ONCE DAILY