BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1803181 · Received August 31, 2007

    Report

    Report Number
    2954323-2007-16217
    Event Type
    Malfunction
    Date Received
    August 31, 2007
    Date of Event
    August 1, 2007
    Report Date
    August 31, 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

    (B)(4). THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES OR ERRORS WERE OBSERVED, ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. THE METER WAS RETURNED AND ACCORDING TO THE MEMORY LOG, THE REPORTED READING BY THE CUSTOMER'S DAUGHTER WAS RECEIVED ON (B)(6), 2007. IN ADDITION, THE CUSTOMER'S DAUGHTER MENTIONED THAT ON (B)(6), 2007, IN THE EVENING, HER DAD WAS EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA SUCH AS SWEATING PROFUSELY AND THEN STARTED TO HAVE A SEIZURE. THE DAUGHTER CALLED THE AMBULANCE TO TRANSPORT THE CUSTOMER TO A MEDICAL FACILITY AND THEY GAVE HIM A GLUCOSE TUBE. WHEN THE CUSTOMER ARRIVED AT THE EMERGENCY ROOM THEY GAVE HIM 2 GLUCOSE TUBES AND AN IV WITH GLUCOSE. PER THE METER'S MEMORY LOG, THE READINGS RECORDED FOR THAT DAY WERE 32 MG/DL AT 18:39, 31 MG/DL, AT 18:41 AND 33 MG/DL AT 18:44. THE READINGS ARE CONSISTENT WITH THE SYMPTOMS AND THE TREATMENT REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER'S DAUGHTER REPORTED RECEIVING INACCURATE READINGS ON THEIR PRECISION XTRA METER. CUSTOMER RECEIVED READINGS OF 242 MG/DL COMPARED TO A LAB READING OF 115 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "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 40890

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK