BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ACTIVE TEST STRIPS

    MDR report key: 3103193 · Received May 9, 2013

    Report

    Report Number
    1823260-2013-02835
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 10 MG/DL AND 233 MG/DL WITHIN 10 MINUTES ON THE ACTIVE SYSTEM. THESE RESULTS WERE FOUND DURING A DATA DOWNLOAD OF THE DEVICE BY THE CUSTOMER. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203283 ACCU-CHEK ® ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 23457931

    Patients

    Seq Age Sex Outcome Treatment
    1