BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1080239 · Received July 21, 2008

    Report

    Report Number
    2954323-2008-02298
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 21, 2008
    Manufacturer
    ABBOTT DIABETES CARE LIMITS UL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE METER IS RETURNED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON HIS PRECISION XTRA/OPTIUM BLOOD GLUCOSE METER WITHIN 10 MINUTES. RESULTS OF 26 MG/DL AND 110 MG/DL WERE PLOTTED ON A PARKES ERROR GRID AND FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE CUSTOMER ALSO REPORTED EXPERIENCING SYMPTOMS OF HEADACHES AND DIZZINESS, BUT THE CUSTOMER DID NOT REPORTEDLY LOSE CONSCIOUSNESS. THE CUSTOMER REPORTED TAKING GLUCOSE TABLETS TO ALLEVIATE THE SYMPTOMS. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED. 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 MONITORING SYSTEM NBW ABBOTT DIABETES CARE LIMITS UL NA 42813

    Patients

    Seq Age Sex Outcome Treatment
    1 NA