BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1760140 · Received July 16, 2010

    Report

    Report Number
    2954323-2010-00951
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    June 18, 2010
    Report Date
    July 16, 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 CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. NOTE: THE DATE OF MANUFACTURE FOR THE METER IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER REPORTED CUSTOMER RECEIVED AN UNSPECIFIED ERROR MESSAGE FROM HIS PRECISION XTRA METER. CUSTOMER'S DAUGHTER STATED CUSTOMER WAS USING EXPIRED TEST STRIPS; HOWEVER, IT IS UNKNOWN IF IT CASED THE ERROR MESSAGE. CUSTOMER'S DAUGHTER ALSO REPORTED CUSTOMER EXPERIENCED SYMPTOMS OF LIGHTHEADEDNESS, HEAVINESS IN THE BODY AND SEIZURE AND HAD JUICE AND SOMETHING SWEET TO COUNTERACT HIS SYMPTOMS. CUSTOMER'S DAUGHTER FURTHER REPORTED CUSTOMER WAS TREATED WITH UNKNOWN TREATMENT BY A HEALTH CARE PRACTITIONER. IT IS ALSO UNKNOWN IF THERE WAS ANY DIAGNOSIS GIVEN BY THE HEALTH CARE PRACTITIONER. ADC CUSTOMER SERVICES ATTEMPTED TO CONTACT CUSTOMER FOR ADDITIONAL INFORMATION BUT WITHOUT ANY SUCCESS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 43348

    Patients

    Seq Age Sex Outcome Treatment
    1 Other