BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2042732 · Received April 6, 2011

    Report

    Report Number
    2954323-2011-02850
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 6, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE DID NOT INVOLVE A PRODUCT MALFUNCTION. SINCE THE MEDICAL EVENT WAS RELATED TO A TRAINING ISSUE, NO INVESTIGATION OF THE PRODUCT IS REQUIRED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CALLED IN REQUESTING CALIBRATION TRAINING AND REPORTED EXPERIENCING VERTIGO, NAUSEA, HOT FLASHES AND HYPERTENSION. THE CUSTOMER REPORTEDLY WAS SEEN BY A DOCTOR AND GIVEN METFORMIN WHICH WAS A CHANGE TO THEIR NORMAL REGIMEN. THE CUSTOMER DID NOT KNOW IF THEY WERE DIAGNOSED WITH HYPO- OR HYPERGLYCEMIA. ADC WAS UNABLE TO VERIFY WHETHER IT WAS A NEWLY PRESCRIBED MEDICATION OR THE ADJUSTMENT. 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
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001A786

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention