BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2251926 · Received September 16, 2011

    Report

    Report Number
    1823260-2011-04911
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 23, 2011
    Report Date
    October 13, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 418 MG/DL, HI, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL, AND 124 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT 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 303166

    Patients

    Seq Age Sex Outcome Treatment
    1 079 YR LANTUS| WATER PILL| METFORMIN| NOVOLOG| CPAP MACHINE