BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1760275 · Received July 16, 2010

    Report

    Report Number
    2954323-2010-00957
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    June 23, 2010
    Report Date
    July 16, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED BACK FOR INVESTIGATION, AND A SUPPLEMENTAL REPORT WILL BE SENT ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AN ADC CUSTOMER REPORTED THEY HAVE BEEN EXPERIENCING MISSING SEGMENTS ON THE DISPLAY OF THEIR PRECISION XTRA METER FOR OVER 3 MONTHS. THEY REPORTED THAT ON 23JUNE2010 AS A RESULT OF THIS ISSUE THEY WERE "GUESSING WHAT THE READINGS WERE" AND THEIR SUGAR "BECAME LOW", WAS PALE AND INCOHERENT. PARAMEDICS WERE CALLED AND CUSTOMER WAS TREATED ON ARRIVAL WITH AN INTRAVENOUS SOLUTION CONTAINING A 50% DEXTROSE INJECTION. CUSTOMER WAS NOT TRANSPORTED TO A LOCAL HOSPITAL AND NO DIAGNOSIS OR ADDITIONAL TREATMENT WAS REPORTED. 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 44203

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R