BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1649524 · Received April 2, 2010

    Report

    Report Number
    2954323-2010-00410
    Event Type
    Malfunction
    Date Received
    April 2, 2010
    Date of Event
    March 7, 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 DEVICE HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FINAL REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED.

    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'S DAUGHTER REPORTED THAT ON 3/7/10 CUSTOMER RECEIVED A RESULT OF 79 MG/DL ON HER FREESTYLE LITE BLOOD GLUCOSE METER, WHICH WAS HIGHER THAN SHE FELT, THE FIRST TIME SHE ATTEMPTED TO USE HER METER. IT WAS FURTHER REPORTED CUSTOMER BECAME UNRESPONSIVE AND SUBSEQUENTLY LOST CONSCIOUSNESS. PARAMEDICS WERE CALLED AND AN INTRAVENOUS INFUSION OF DEXTROSE WAS ADMINISTERED. 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1002244

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention