BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ACTIVE TEST STRIPS

    MDR report key: 3842753 · Received June 2, 2014

    Report

    Report Number
    1823260-2014-03908
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 14 MG/DL AND 127 MG/DL WITHIN 10 MINUTES ON THE ACTIVE SYSTEM. THE CUSTOMER WAS HYPOGLYCEMIC. NO REPORT OF ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320830 ACCU-CHEK ® ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 23463733

    Patients

    Seq Age Sex Outcome Treatment
    1 003 YR