BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XCEED PRO

    MDR report key: 1820499 · Received August 30, 2010

    Report

    Report Number
    2954323-2010-01207
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    August 5, 2010
    Report Date
    October 18, 2010
    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 AN INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATIONAL RESULTS ARE AVAILABLE. NOTE: THE DEVICE MANUFACTURE DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER WAS RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    AS CUSTOMER'S PRODUCT WAS NOT RETURNED, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOID COLON RESECTION PROCEDURE THE SURGEON STAPLED THE DISTAL END PROXIMAL WITH A BLUE LOAD. IN THE MIDDLE OF THE POSTERIOR SIDE OF THE STAPLE LINE THERE WERE NO STAPLES. ON ANTERIOR SIDE THERE ARE STAPLES PRESENT BUT THE STAPLE LINE WAS STILL OPEN IN THE MIDDLE. THE DEVICE WAS RELOADED WITH ANOTHER BLUE CARTRIDGE. THE DEVICE FIRED FINE WITH A COMPLETE STAPLE LINE AND THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    A MEDICAL HEALTH CARE REPRESENTATIVE REPORTED THEY COMPARED A READING OF 271 MG/DL OBTAINED ON A PRECISION EXCEED PRO BLOOD GLUCOSE METER TO A LAB RESULT OF 37 MG/DL, AND THOSE TESTS WERE COMPLETED WITHIN TEN MINUTES. THE RESULTS WERE PLOTTED ON A PARKES ERROR GRID AND FELL INTO THE "D" ZONE SHOWING THE DIFFERENCE IN VALUES WAS CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE 810:11. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION, WHICH INTERRUPTED DELIVERY. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.90, WHICH IS CLASSIFIED AS REMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XCEED PRO BLOOD GLUCOSE MONITORING SYSTEM NBW 44215H

    Patients

    Seq Age Sex Outcome Treatment
    1