BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1903767 · Received November 20, 2010

    Report

    Report Number
    2954323-2010-01577
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    November 3, 2010
    Report Date
    December 29, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED METER (B)(4) AND STRIP LOT NUMBER 1004031. THE COMPLAINT WAS NOT CONFIRMED AND ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. IN ADDITION, TWO OF THE FOUR READINGS REPORTED WERE FOUND IN THE INTERNAL MEMORY LOG OF THE METER AND WERE TAKEN IN 10 MINUTES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC METER. CUSTOMER REPORTED RECEIVING READINGS OF 500 MG/DL, 134 MG/DL, 56 MG/DL AND 118 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE CUSTOMER ALSO REPORTED EXPERIENCING UNSPECIFIED SYMPTOMS, HOWEVER, REFUSED TO PROVIDE ANY FURTHER INFORMATION. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A READINGS ISSUE ON THEIR ADC METER WHILE USING AN AFFECTED TEST STRIP LOT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1004031

    Patients

    Seq Age Sex Outcome Treatment
    1