BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 1598665 · Received February 12, 2010

    Report

    Report Number
    2954323-2010-00155
    Event Type
    Malfunction
    Date Received
    February 12, 2010
    Date of Event
    January 17, 2010
    Report Date
    July 7, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (B) (4) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    1. A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO ERRONEOUS LOW VANCOMYCIN (VANC) RESULT GENERATED BY SYNCHRON LX20 PRO ANALYZER.2. THE SAMPLE WAS RERUN AND HIGHER RESULT WAS OBTAINED. THE INITIAL AND REPEAT RESULTS ARE PROVIDED IN SECTION B63. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY.4. PATIENT TREATMENT WAS NOT IMPACTED BASED ON THE ERRONEOUS RESULTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A GLUCOSE READING OF 232 MG/DL FROM HER FREESTYLE METER WHICH WAS HIGHER THAN THEY FELT. THE CUSTOMER SELF-ADMINISTERED HER INSULIN MEDICATION ACCORDINGLY. AS A RESULT, CUSTOMER REPORTED EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS AND EATING FOOD AND DRINKING JUICE TO COUNTERACT HER SYMPTOMS. PARAMEDICS WERE CALLED AND THEY CHECKED CUSTOMER'S VITAL SIGNS AND TREATED CUSTOMER WITH JUICE. THERE WAS NO REPORT OF DIAGNOSIS, DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM NBW 0816521

    Patients

    Seq Age Sex Outcome Treatment
    1 Other