BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 4252315 · Received November 14, 2014

    Report

    Report Number
    2954323-2014-01122
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 26, 2014
    Report Date
    October 28, 2014
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    PMA / PMN Number
    K040814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: ALTHOUGH TREATMENT IS UNKNOWN, IT CAN BE CONCLUDED THAT A BLOOD GLUCOSE RESULT OF 31 MG/DL WOULD NECESSITATE TREATMENT TO RAISE BLOOD GLUCOSE LEVELS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HE WAS UNABLE TO TEST USING HIS WIFE'S ADC BLOOD GLUCOSE METER DUE TO THE METER NOT POWERING ON WITH BUTTON PRESS OR TEST STRIP INSERTION. CUSTOMER FURTHER REPORTED PARAMEDICS WERE CALLED AND UPON THEIR ARRIVAL, A READING OF 31 MG/DL WAS OBTAINED ON THE PARAMEDIC METER AND HE WAS TRANSPORTED TO A LOCAL HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER REGARDING THE MEDICAL EVENT AS HE DECLINED TO CONTINUE TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737397 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention