BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2162815 · Received July 15, 2011

    Report

    Report Number
    2954323-2011-03855
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 12, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE NOTICED A NO STRIP MESSAGE ON HIS ADC BLOOD GLUCOSE METER AFTER THE SAMPLE WAS APPLIED AND HIS METER WAS NOT DISPLAYING A READING. CUSTOMER FURTHER REPORTED SUBSEQUENTLY EXPERIENCED LOST OF CONSCIOUSNESS. PARAMEDICS WERE CALLED AND THE CUSTOMER WAS TRANSPORTED TO THE HOSPITAL. CUSTOMER WAS TREATED WITH GLUCOSE INTRAVENOUSLY. IN THE HOSPITAL, CUSTOMER WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA. CUSTOMER STAYED IN THE HOSPITAL FOR COUPLE OF DAYS. CUSTOMER WAS UNSURE ON WHAT TREATMENT WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001F072

    Patients

    Seq Age Sex Outcome Treatment
    1 Other