BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 2061602 · Received April 18, 2011

    Report

    Report Number
    2954323-2011-02985
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 27, 2011
    Report Date
    September 19, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS NOT CONFIRMED. THE RETURNED METER WAS INVESTIGATED. CONTROL SOLUTION TESTING WAS PERFORMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. NO NEW ISSUES WERE OBSERVED.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ER-4 MESSAGE ON THE DISPLAY OF HIS FREESTYLE BLOOD GLUCOSE METER. HE FURTHER REPORTED SUBSEQUENTLY EXPERIENCING LIGHTHEADEDNESS, VERTIGO AND DIFFICULTY AMBULATING. CUSTOMER ADDITIONALLY NOTED EXPERIENCING BOTH A LOSS OF CONSCIOUSNESS AND A SEIZURE. CUSTOMER SELF-PRESENTED TO HIS HEALTHCARE PROVIDER AND WAS REPORTEDLY DIAGNOSED WITH DKA (DIABETIC KETOACIDOSIS), BUT RECEIVED NO THIRD-PARTY EMERGENT MEDICAL INTERVENTION. CUSTOMER NOTED HE WAS GIVEN "OXYGEN TESTS, STRESS TESTS AND BLOOD TESTS". CUSTOMER ADDITIONALLY SELF-TREATED WITH DEPAKOTE. ATTEMPTS TO CONTACT THE CUSTOMER TO GATHER ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM NBW 0535327

    Patients

    Seq Age Sex Outcome Treatment
    1 Other