BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1677113 · Received May 7, 2010

    Report

    Report Number
    2954323-2010-00647
    Event Type
    Malfunction
    Date Received
    May 7, 2010
    Date of Event
    April 13, 2010
    Report Date
    July 6, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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 THE INVESTIGATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION HOWEVER, AS OF THIS DATE NO PRODUCT HAS BEEN RETURNED. RETAIN TESTING OF LOT # RETAIN TESTING FOR STRIP LOT #1051417 WAS PERFORMED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE MONITOR WITHIN 10 MINUTES OF 26.8 MMOL/L, 24.4 MMOL/L AND 4.2 MMOL/L. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A FALSELY ELEVATED POTASSIUM (7.7 MMOL/L) RESULT ON THE ARCHITECT C16000. THE SPECIMEN WAS RETESTED WITH A POTASSIUM IN THE NORMAL RANGE (4.0 MMOL/L). THE FALSELY ELEVATED POTASSIUM RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1