BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SENSOR COMFORT TEST STRIPS

    MDR report key: 1930371 · Received December 16, 2010

    Report

    Report Number
    1823260-2010-07503
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 24, 2010
    Report Date
    December 16, 2010
    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

    CALLER STATES PATIENT TESTED OF 19.4 MMOL/L AND 8.5 MMOL/L WITHIN 10 MINUTES ON THE INFORM SYSTEM. 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 ® SENSOR COMFORT TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 571408

    Patients

    Seq Age Sex Outcome Treatment
    1