BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2143316 · Received June 29, 2011

    Report

    Report Number
    1823260-2011-03507
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 11, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 486 MG/DL AND 205 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. AT ANOTHER TIME, THE REPORTER ALSO ALLEGED OBTAINING THE RESULTS OF 400 MG/DL, 405 MG/DL, AND 110 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE SAME AVIVA SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 303242

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR LANTUS| ASPIRIN| DILTIAZEM| SIMVASTATIN| BLOOD PRESSRURE MACHINE| AMLODIPINE BESYLATE| METFORMIN