BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1874146 · Received October 19, 2010

    Report

    Report Number
    1823260-2010-06198
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 453 MG/DL, 70 MG/DL, AND 65 MG/DL. CUSTOMER APPEARED TO BE CLAMMY AND PALE WITH GLASSY EYES WHEN OBTAINING THE ERRATIC READINGS. HER CARETAKER TREATED THE CUSTOMER WITH 1 GLUCOSE PILL AND ICE CREAM CAKE TO BRING HER BLOOD SUGAR BACK UP. THE CUSTOMER APPEARED TO FEEL BETTER INSTANTLY. 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 302273

    Patients

    Seq Age Sex Outcome Treatment
    1 081 YR LEVOPHYROXINE| NOVOLOG 70 30| LISINOPRIL| CARBIDOPA / LEVODOPA| SIMVASTATIN