BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2932050 · Received January 28, 2013

    Report

    Report Number
    2954323-2013-00063
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 12, 2013
    Report Date
    January 18, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING UNABLE TO TEST DUE TO RECEIVING A LOW BATTERY ICON ON HER ADC METER. CUSTOMER FURTHER REPORTED EXPERIENCING SYMPTOMS THAT WERE DESCRIBED AS "SWEATING, BLURRED VISION, CONFUSION, STAGGERING, AND SHAKY" WHICH RESULTED IN HAVING A LOSS OF CONSCIOUSNESS. CUSTOMER REPORTED SELF-TREATING WITH "DEXTROSE AND 3 JOLLY RANCHERS". PARAMEDICS WERE CALLED, OBTAINED A READING OF 2 MMOL/L (36 MG/DL) AND THEN TREATED CUSTOMER WAS ORANGE JUICE AND OBTAINED A READING OF 4.2 MMOL/L (76 MG/DL). IT WAS ALSO REPORTED THAT PARAMEDICS TREATED CUSTOMER WITH "GLUCOSE GEL AND INJECTION". THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38207 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R