BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1661195 · Received April 18, 2010

    Report

    Report Number
    2954323-2010-00517
    Event Type
    Malfunction
    Date Received
    April 18, 2010
    Date of Event
    March 16, 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

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE PRODUCT IS RETURNED AND INVESTIGATION IS COMPLETE.

    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

    A CUSTOMER REPORTED THAT ON (B) (6) 2010, THEY RECEIVED A READING OF 193 MG/DL AT 7:00 AM ON THEIR BLOOD GLUCOSE METER, AND THEY THOUGHT THE METER WAS READING HIGHER THAN THEY FELT. THE CUSTOMER REPORTEDLY EXPERIENCED DIZZINESS AND LOSS OF CONSCIOUSNESS. THE PARAMEDICS WERE CALLED AND THE CUSTOMER WAS REPORTEDLY TREATED WITH "TWO GLUCOSE SHOTS". THE CUSTOMER ALSO REPORTED EATING AND DRINKING TO ALLEVIATE THEIR SYMPTOMS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0936326

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R