BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2130749 · Received June 16, 2011

    Report

    Report Number
    2954323-2011-03571
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 31, 2011
    Report Date
    August 11, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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.

    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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING A READING OF 338 MG/DL ON THEIR XTRA METER AND SELF-DOSING WITH INSULIN BASED ON THAT READING. THE CUSTOMER REPORTEDLY WENT TO (B)(6) AND FELL DOWN HITTING HER HEAD AND PASSED OUT - "FELL ON CONCRETE FLOOR BUT DOES NOT KNOW IF SHE FELL, DOES NOT REMEMBER ANYTHING NOT EVEN WALKING INTO (B)(6)." THE PARAMEDICS ARRIVED ON THE SCENE AND ADMINISTERED "SUGAR OF SOME KIND" VIA INTRAVENOUS INFUSION. THE CUSTOMER ALSO REPORTED SHE OBTAINED A READING OF 147MG/DL ON HER XTRA METER THAT WAS LOWER WHEN COMPARED TO A READING OF 194 MG/DL ON PARAMEDIC'S METER OF UNKNOWN BRAND. THE CUSTOMER WAS NOT TRANSPORTED TO A HEALTH CARE FACILITY. 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 45001F231

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R