BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA / OPTIUM

    MDR report key: 1020153 · Received May 25, 2007

    Report

    Report Number
    2954323-2007-08868
    Event Type
    Malfunction
    Date Received
    May 25, 2007
    Date of Event
    April 27, 2007
    Report Date
    May 25, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES OR ERRORS WERE OBSERVED. ALL RESULTS WERE WITHIN RANGE SPEC DURING CONTROL SOLUTION TESTING AND IT WAS NOTED THAT THE YEAR WAS SET INCORRECTLY ON THE METER. ON THE DATE OF THE REPORTED EVENT THE METER RECORDED A READING OF 116 MG/DL, THE READING REPORTED BY THE CUSTOMER IS NOT PRESENT IN THE METER'S MEMORY LOG.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A READING OF 183 MG/DL ON HIS PRECISION XTRA BLOOD GLUCOSE MONITOR, WHICH HE FELT WAS TOO HIGH AND WENT TO HOSP. THE HOSP'S LAB NOTED HIS BLOOD GLUCOSE LEVEL TO BE 93 MG/DL. THE RESULTS WHEN PLOTTED ON A PARKES TO BE CLINICALLY "C" 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 XTRA / OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NA 41376

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK