BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREE STYLE

    MDR report key: 386557 · Received April 3, 2002

    Report

    Report Number
    2954323-2002-00025
    Event Type
    Malfunction
    Date Received
    April 3, 2002
    Date of Event
    March 14, 2002
    Report Date
    April 2, 2002
    Manufacturer
    THERASENSE, INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER INDICATED THEY RECEIVED READINGS OF 339 AND 330 MG/DL WITHIN 10 MINUTES. AFTER A LAPSE OF 15 MINUTES, 4 ADDITIONAL TESTS WERE CONDUCTED WITH READINGS OF 104, 116, 140, 147 MG/DL. TIME ELAPSED BETWEEN EACH TEST DID NOT EXCEED 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREE STYLE BLOOD GLUCOSE MONITORING SYSTEM LFR THERASENSE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN MEDICATION: GLUCOPHAGE, GLUCOTROL XL AVANDIA.