BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1832266 · Received September 13, 2010

    Report

    Report Number
    1823260-2010-05379
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 13, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 320 MG/DL AND 118 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. CUSTOMER STATES HE WAS EATING AND DID NOT WASH HIS HANDS AND HAD FOOD ON THEM WHEN HE DID THE TESTS. 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 302395

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR HUMULIN R| LANTUS ONCE DAILY| SECOND AVIVA METER