BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1991683 · Received February 15, 2011

    Report

    Report Number
    2954323-2011-01632
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 15, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DELIVERY ISSUE. NO FURTHER INVESTIGATION IS REQUIRED. THIS IS THE FINAL REPORT. NOTE: THE DATE OF THE EVENT IS UNKNOWN; THE DEVICE MANUFACTURE DATE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED HE DID NOT RECEIVE HIS TEST STRIP PRODUCT REPLACEMENT AND THEREFORE HE WAS UNABLE TO TEST. AS A RESULT, THE CUSTOMER REPORTED HE PASSED OUT AND DRANK ORANGE JUICE. THE CUSTOMER REPORTEDLY REFUSED TO COMPLETE THE MEDICAL TROUBLESHOOTING SURVEY QUESTIONS. 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 45001A669

    Patients

    Seq Age Sex Outcome Treatment
    1 Other