BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION XTRA MONITOR

    MDR report key: 379845 · Received February 26, 2002

    Report

    Report Number
    1220459-2002-00014
    Event Type
    Death
    Date Received
    February 26, 2002
    Date of Event
    November 1, 2001
    Report Date
    February 22, 2002
    Manufacturer
    MEDISENSE, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON JANURAY 29, 2002, INFORMATION WAS RECEIVED FROM AN INTERNATIONAL HOSPITAL THAT A PATIENT WAS TESTED ON THE HOSPITAL'S MEDISENSE OPTIUM METER WITH A GLUCOSE STRIP GIVING A RESULT OF "HI". AN ADDITIONAL TEST WAS TAKEN WITH A KETONE STRIP WITH A RESULT 0.1 MMOL/L. INSULIN TREATMENT WAS ADMINISTRATED. APPROXIMATELY ONE HOUR LATER, URINE AND VENOUS BLOOD WERE TESTED AND THE BLOOD GAVE A PH VALVE OF 6.9. THE URINE KETONE TESTING GAVE A RESULT OF ++++. THE PATIENT EXPIRED 5-10 MINUTES AFTER THIS TESTING. IT IS INCONCLUSIVE IF ANY MEDISENSE PRODUCT CONTRIBUTED TO THE REPORTER'S DEATH. MEDISENSE HAS BEEN UNABLE TO RETRIEVE ANY ADDITIONAL INFORMATION FROM THE PHYSICIAN AS TO THE CAUSE OF DEATH ON THE TREATMENT ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA MONITOR BLOOD GLUCOSE METER CFR MEDISENSE, INC. NA 87981/70142

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death