BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1992228 · Received February 15, 2011

    Report

    Report Number
    2954323-2011-01637
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 15, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE METER'S SN IS NOT KNOWN THE DATE PROVIDED IS THE MANUFACTURER'S AWARENESS DATE. THE CUSTOMER'S METER HAS BEEN REQUESTED BACK FOR INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SENT ONCE NEW INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    AN ADC CUSTOMER REPORTED RECEIVING AN ERROR 759 ON THEIR PXTRA METER, WAS UNABLE TO TEST AND REPORTED EXPERIENCING SYMPTOMS OF DIZZINESS AND SHAKES. PARAMEDICS WERE REPORTEDLY CALLED, ORAL GLUCOSE WAS ADMINISTERED ON SCENE AND THE CUSTOMER WAS TRANSPORTED TO A HEALTH CARE FACILITY. CUSTOMER WAS THEN DIAGNOSED WITH HYPOGLYCEMIA AND "GIVEN MEDICATION (NOT SPECIFIED) AND THEN PUT UNDER HOSPITAL OBSERVATION TO STABILIZE HER GLUCOSE LEVELS." NO ADDITIONAL INFORMATION OR SPECIFIC MEDICAL TREATMENT WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45777

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R