BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1941412 · Received December 29, 2010

    Report

    Report Number
    1823260-2010-07738
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 20, 2010
    Report Date
    February 17, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 304 MG/DL, 287 MG/DL AND 137 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE 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 302652

    Patients

    Seq Age Sex Outcome Treatment
    1 NOVOLIN NPH (SLIDING SCALE)| GLYBURIDE (TWICE DAILY)