BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2020810 · Received March 16, 2011

    Report

    Report Number
    2954323-2011-02251
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 24, 2011
    Report Date
    April 20, 2011
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION WAS PERFORMED ON THE RETURNED METER SERIAL NUMBER (B)(4) AND TEST STRIPS LOT NUMBER 45001A333. 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. THE READING THE CUSTOMER REPORTED WAS FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE FACILITY'S ADC PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SENT ONCE NEW INFORMATION IS OBTAINED. THE MANUFACTURE DATE FOR SECOND METER SN# (B)(4) IS 12/11/2007. NOTE: PRODUCT LABEL COPY STATES THAT "TEST RESULTS MAY BE ERRONEOUSLY LOW IF A PATIENT IS SEVERELY DEHYDRATED, OR SEVERELY HYPOTENSIVE, IN SHOCK OR HYPERGLYCEMIC-HYPEROSMOLAR STATE (WITH OR WITHOUT KETOSIS). SIMILAR OBSERVATIONS HAVE BEEN REPORTED IN THE LITERATURE FOR OTHER BLOOD GLUCOSE MONITORING SYSTEMS."

    Description of Event or Problem · 1

    AN ADC CUSTOMER HEALTH CARE FACILITY REPORTED THAT AN ADC METER READ LOWER THAN A LABORATORY RESULT. SPECIFICALLY THEY REPORTED THAT (2) XCEED METERS GAVE LOWER VALUES AS COMPARED TO A LABORATORY READING FOR A PATIENT THAT WAS SEVERELY DEHYDRATED AT THE TIME THE SPECIMENS WERE OBTAINED. METER SN (B)(4) OBTAINED A READING OF 300MG/DL AND WAS COMPARED TO A LABORATORY RESULT OF 1000MG/DL WHILE METER SN (B)(4) OBTAINED A READING OF 355MG/DL AND WAS ALSO COMPARED TO THE LABORATORY RESULT OF 1000MG/DL. WHEN PLOTTED ON THE PARKES ERROR GRID, THE RESULTS FELL OUT OF RANGE INDICATING THE DIFFERENCE IN VALUES IS CONSIDERED CLINICALLY SIGNIFICANT. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA, HOWEVER NO INFORMATION WITH REGARDS TO THE MEDICAL TREATMENT WAS PROVIDED. 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 XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001A333

    Patients

    Seq Age Sex Outcome Treatment
    1