BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1791986 · Received August 10, 2010

    Report

    Report Number
    2954323-2010-01093
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 8, 2010
    Report Date
    August 10, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DELIVERY ISSUE AND IT DOES NOT INVOLVE A PRODUCT MALFUNCTION. NO FURTHER INVESTIGATION IS REQUIRED. ADC CUSTOMER SERVICE SUCCESSFULLY ARRANGED A FIELD EXCHANGE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A CALLER REPORTED THE CUSTOMER DID NOT RECEIVE THEIR PRECISION XTRA REPLACEMENT METER, AND THE CUSTOMER EXPERIENCED WEAKNESS, LIGHTHEADEDNESS AND LOSS OF CONSCIOUSNESS. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED. IT WAS ADDITIONALLY REPORTED THE CUSTOMER TOOK THEIR MEDICATIONS, BUT THE CALLER DID NOT WISH TO PROVIDE THEIR NAMES. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other