BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XCEED PRO

    MDR report key: 1960692 · Received January 13, 2011

    Report

    Report Number
    2954323-2011-00653
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 16, 2010
    Report Date
    February 10, 2011
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE METER IS DESIGNED TO REPORT READINGS OF 20 MG/DL TO 500 MG/DL. IT SHOULD BE NOTED THAT THIS METER DOES NOT GIVE A NUMERIC VALUE FOR READINGS LESS THAN 20 MG/DL. A READING LESS THAN 20 MG/DL WOULD DISPLAY A " <20 MG/DL" MESSAGE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER WAS RETURNED AND INVESTIGATED. THE READINGS COMPLAINT IS NOT CONFIRMED. THE METER POWERED ON DURING INVESTIGATION. THE METER WAS DISASSEMBLED AND DAMAGE TO THE COMMUNICATION PORT CONNECTOR WITHIN THE DIGITAL BOARD WAS OBSERVED. IN ADDITION, CONTAMINATION WAS OBSERVED WITHIN THE STRIP PORT. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED A PRECISION XCEED PRO METER THAT READS LOW RESULTS (<20) COMPARED TO THE LAB RESULTS OF 317, 296 AND 131 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "D" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. 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 PRECISION XCEED PRO BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1