BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION PCX

    MDR report key: 1801453 · Received July 9, 2007

    Report

    Report Number
    2954323-2007-11805
    Event Type
    Malfunction
    Date Received
    July 9, 2007
    Date of Event
    June 5, 2007
    Report Date
    July 5, 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 CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    THE HEALTH CARE PROVIDER REPORTED RECEIVING INACCURATE READINGS ON THE CUSTOMER'S PRECISION PCX BLOOD GLUCOSE MONITOR. CUSTOMER RECEIVED READINGS OF 430 MG/DL COMPARED TO A LAB READING OF 900 MG/DL. IT IS UNK WHETHER THE READINGS WERE DONE WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL OUT OF RANGE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT. IT IS TO BE NOTED THAT PRODUCT LABELING STATES THAT "TEST RESULTS MAYBE ERRONEOUSLY LOW IF THE PATIENT IS IN A HYPERGLYCEMIC-HYPEROSMOLAR STATE (WITH OR WITHOUT KETOSIS)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION PCX BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK