BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1823129 · Received September 1, 2010

    Report

    Report Number
    2954323-2010-01213
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    August 11, 2010
    Report Date
    September 1, 2010
    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. THE FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATIONAL RESULTS ARE AVAILABLE. NOTE: DURING A TROUBLESHOOTING WITH ADC CUSTOMER SERVICE, IT WAS DISCOVERED THAT CUSTOMER HAD NOT REPLACED BATTERIES. NOTE: THE DEVICE MANUFACTURE DATE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED ABOUT SIX MONTH AGO HIS METER STOPPED TURNING ON AND HAD NO POWER AND AS A RESULT OF BEING UNABLE TO TEST, HE EXPERIENCED A HYPERGLYCEMIC EPISODE. HE FURTHER REPORTED HE WAS ADMITTED TO THE HOSPITAL WHERE HE WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH INSULIN AND INTRAVENOUS INFUSION FOR DEHYDRATION. 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 44377

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R