BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2012142 · Received March 9, 2011

    Report

    Report Number
    1823260-2011-01292
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 27, 2011
    Report Date
    September 2, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS TREATING LOW BLOOD GLUCOSE SYMPTOMS WITH RAISIN BREAD AND A PIECE OF CHEESE. CUSTOMER THEN RECEIVED RESULTS OF 24.2 MMOL/L AND 5.2 MMOL/L WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO ADVERSE EVENT RELATED TO THE DEVICE WAS 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 202830

    Patients

    Seq Age Sex Outcome Treatment
    1 033 YR METFORMIN| NOVOLIN NPH| HUMALOG