BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK® AVIVA TEST STRIPS

    MDR report key: 1981909 · Received February 8, 2011

    Report

    Report Number
    1823260-2011-00700
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR THE AVIVA METER. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 300 MG/DL (ADVANTAGE) AND 128 MG/DL (AVIVA) NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 ROCHE DIAGNOSTICS NA 303191

    Patients

    Seq Age Sex Outcome Treatment
    1 057 YR LISINOPRIL 1X DAILY| DAVAPENTIN 1X DAILY| IV ANTIBIOTIC FOR BLADDER INFECTION| LANTUS| SIMVASTATIN 1X DAILY| FERROUS SULFATE| CLONIDINE 1X DAILY