BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2020808 · Received March 16, 2011

    Report

    Report Number
    2954323-2011-02252
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 25, 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 AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED METER SERIAL NUMBER (B)(4). INVESTIGATION FOR REPORTED ISSUE WAS UNABLE TO BE CONDUCTED; DUE TO THE KNOWN ISSUE OF DISPLAY DAMAGE ((B)(4)).

    Description of Event or Problem · 1

    A PARAMEDIC CALLED ADC TO REPORT A SITUATION WHERE A MAN WAS FOUND UNDER THE INFLUENCE OF NARCOTICS AND UNRESPONSIVE, THE PARAMEDICS TOOK HIS GLUCOSE READING ON THEIR PRECISION XTRA METER AND OBTAINED A RESULT OF 357MG/DL. NO TREATMENT WAS RENDERED BY PARAMEDICS AND WHEN THEY ARRIVED AT THE HOSPITAL 10 MINUTES LATER, THE UNSPECIFIED LOW READINGS WERE OBTAINED TWICE ON HCP METER. THE PATIENT WAS REPORTEDLY DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH DEXTROSE 50% . THE CALLER DID NOT HAVE ANY ADDITIONAL INFO WITH REGARDS TO THE TREATMENT PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45281

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention