BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2080710 · Received May 6, 2011

    Report

    Report Number
    2954323-2011-03206
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 17, 2011
    Report Date
    May 6, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THERE IS NO INDICATION OF PRODUCT MALFUNCTION. NO INVESTIGATION OF THE PRODUCT IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER CALLED CUSTOMER SERVICE TO REQUEST TRAINING IN HOW TO CODE HIS PRECISION XTRA BLOOD GLUCOSE METER. WHILE ON THE PHONE HE REPORTED THAT TWO DAYS PRIOR TO CALLING ON (B)(6) 2011 HE EXPERIENCED NAUSEA, HAD "STOMACH PAIN" AND FELT "HOT". CUSTOMER SELF-PRESENTED TO HIS HEALTHCARE PROVIDER AND WAS DIAGNOSED WITH HYPERGLYCEMIA. CUSTOMER WAS GIVEN AN INTRAVENOUS INFUSION OF UNKNOWN TYPE IN ADDITION TO AN UNKNOWN AMOUNT OF INSULIN. CUSTOMER DENIED SELF-TREATING. 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 48363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other