BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 822593 · Received November 8, 2004

    Report

    Report Number
    2954323-2004-00448
    Event Type
    Malfunction
    Date Received
    November 8, 2004
    Date of Event
    October 1, 2004
    Report Date
    November 5, 2004
    Manufacturer
    THERASENSE, INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A CONTROL SOLUTION TEST WAS COMPLETED AND RESULTS WERE WITHIN THE APPROPRIATE RANGE. AN ATTEMPT WAS MADE TO COMPLETE A BLOOD GLUCOSE TEST WITH THE CUSTOMER ON THE TELEPHONE, BUT TWO DIFFERENT STRIPS DID NOT PROVIDE A RESULT. CASE WAS NOT CODED PROPERLY UPON INITIAL CONTACT. AN INTERNAL AUDIT IDENTIFIED THE OVERSIGHT AND CASE WAS EVALUATED BY REGULATORY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING INACCURATE ERRATIC READINGS. IN BLOOD GLUCOSE TESTS, CUSTOMER REC'D READINGS OF 122, 221, AND 171 MG/DL WITHIN 10 MINUTES. THE RESULTS VARY BY MORE THAN 20% AND ARE CONSIDERED A MALFUNCTION WHEN COMPARED TO MFR'S SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *