BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2133004 · Received June 17, 2011

    Report

    Report Number
    2954323-2011-03595
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 29, 2011
    Report Date
    August 15, 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.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER, WAS OMITTED IN ERROR ON FOLLOW UP REPORT #1. THE DATE RECEIVED BY MANUFACTURER IS (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. THE STANDARD DEVIATION WAS WITHIN SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READING THE CUSTOMER REPORTED WAS FOUND IN THE METER MEMORY LOG.

    Description of Event or Problem · 1

    CUSTOMER'S NIECE REPORTED THAT THE CUSTOMER HAD A READING OF 90 MG/DL ON HER ADC BLOOD GLUCOSE METER WHICH WAS TAKEN IN THE MORNING AND THEN THE CUSTOMER TOOK A NAP. IN THE AFTERNOON, THE CUSTOMER EXPERIENCED DIFFICULTY OF WAKING UP AND LOSS OF CONSCIOUSNESS AND PARAMEDICS WAS CALLED. THE CUSTOMER HAD A READING OF 42 MG/DL FROM THE PARAMEDIC'S BLOOD GLUCOSE METER. THE CUSTOMER WAS TREATED WITH ORAL ORANGE JUICE WITH SUGAR ADDED AND WITH FOOD. PER CUSTOMER'S DAUGHTER, THE CUSTOMER DID NOT EXPERIENCE ANY INJURY. THE CUSTOMER WAS NOT TRANSPORTED TO THE HOSPITAL. 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 45001A656

    Patients

    Seq Age Sex Outcome Treatment
    1 Other