BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ACTIVE TEST STRIPS

    MDR report key: 2832284 · Received November 14, 2012

    Report

    Report Number
    1823260-2012-05759
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 17, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THE FOLLOWING RESULTS ON THE ACTIVE SYSTEM: 16 MG/DL, 20 MG/DL, AND 18 MG/DL. CUSTOMER TESTED 190 MG/DL ON A PROFESSIONAL METER; ALL RESULTS WERE OBTAINED WITHIN 10 MINUTES OF EACH OTHER. CUSTOMER KEEPS WOOL WITH ALCOHOL IN AN EMPTY ACTIVE TEST STRIP VIAL; IT MAY BE POSSIBLE THAT THE CUSTOMER SWITCHED THE CAPS ON THE TEST STRIP VIALS. NO 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
    1 ACCU-CHEK ® ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 23451131

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR