BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1220058 · Received October 31, 2008

    Report

    Report Number
    1823260-2008-08065
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED BLOOD GLUCOSE RESULTS OF 330 MG/DL, 163 MG/DL, AND 248 MG/DL WHEN TESTING WAS PERFORMED BACK-TO-BACK ON THE ACTIVE S SYSTEM. CUSTOMER REPORTED HAVING NO SYMPTOMS OR TREATMENT. NO SERIOUS ADVERSE EVENT WAS HAVING IN CONNECTION WITH THE ALLEGED MALFUNCTION. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS-LFR LFR ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK