BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2003409 · Received March 1, 2011

    Report

    Report Number
    2954323-2011-01781
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 14, 2011
    Report Date
    May 4, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER ((B)(4)) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING A READING OF 84 MG/DL IN THE MORNING OF (B)(6) 2011 AND LATER THAT MORNING AT 11:00 AM, HE WAS SITTING ON A STOOL AND STATED HE COULDN'T SEE CLEARLY, PASSED OUT AND FELL OFF THE STOOL BACKWARDS ONTO A CONCRETE FLOOR. THE PARAMEDICS WERE CALLED, TREATED CUSTOMER WITH GLUCOSE GEL AND TRANSPORTED HIM TO A LOCAL HOSPITAL WHERE HE WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH SHOTS OF UNKNOWN TYPE. IN ADDITION, THE CUSTOMER REPORTEDLY HAD FOOD TO COUNTERACT THE EVENT. 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 45001E024

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R