BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2173444 · Received July 23, 2011

    Report

    Report Number
    2954323-2011-03914
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 19, 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 INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE DATE OF THE MEDICAL EVENT AND THE DEVICE MANUFACTURE DATE ARE UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED IN (B)(6) 2010 HE STARTED GETTING AN ER-6 AND ER-7 MESSAGES ON THEIR PRECISION XTRA METER AND AS RESULT EXPERIENCED LACK OF ENERGY AND VERTIGO. THE CUSTOMER REPORTEDLY SELF-PRESENTED TO HIS HEALTH CARE PROVIDER, WAS DIAGNOSED WITH DOUBLE PNEUMONIA, GANGRENE DUE TO RUPTURED APPENDIX AND WAS PLACED ON INSULIN WHEN IN THE HOSPITAL. THE CUSTOMER ADDITIONALLY REPORTED HE SELF-TREATED WITH VITAMINS AND FOOD IN ATTEMPT TO ALLEVIATE THE SYMPTOMS. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention