BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XCEED PRO

    MDR report key: 1912033 · Received December 1, 2010

    Report

    Report Number
    2954323-2010-01623
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 12, 2010
    Report Date
    May 2, 2011
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER'S MANUFACTURE DATE IS UNKNOWN. THE FACILITY'S ADC PRODUCTS HAVE BEEN REQUESTED BACK FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SENT ONCE NEW INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION AND THE STANDARD DEVIATION WAS WITHIN SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. NOTE: THIS FOLLOW UP IS BEING SENT AS FOLLOW-UP #1 DID NOT RECEIVE THE THIRD ACKNOWLEDGMENT AFTER BEING SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION AND THE STANDARD DEVIATION WAS WITHIN SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Description of Event or Problem · 1

    AN ADC CUSTOMER USER FACILITY REPRESENTATIVE REPORTED A PRECISION XCEED PRO METER READING OF 494MG/DL COMPARED TO THE FACILITY'S LAB READING OF 117MG/DL OBTAINED ON A PATIENT WITHIN 10 MINUTES USING A CAPILLARY SAMPLE. WHEN PLOTTED ON THE PARKES ERROR GRID THE RESULTS FELL WITHIN THE "D" ZONE SHOWING THE DIFFERENCE IN VALUES IS CONSIDERED CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XCEED PRO BLOOD GLUCOSE MONITORING SYSTEM NBW 44CH5H

    Patients

    Seq Age Sex Outcome Treatment
    1