BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 585625 · Received March 29, 2005

    Report

    Report Number
    2954323-2005-00093
    Event Type
    Injury
    Date Received
    March 29, 2005
    Date of Event
    March 12, 2005
    Report Date
    March 29, 2005
    Manufacturer
    THERASENSE, INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY TOOK TOO MUCH INSULIN BASED ON READINGS FROM THE PRECISION XTRA AND HAD TO GO TO THE HOSP. THE FOLLOWING RESUTLS WER RECEIVED IN THE HOURS PRECEDING THE VISIT TO THE HOSP AT 5:00 PM: 160, 208, 215, 477, 372, 246, 188 MG/DL, AND HI. THE LAST READING WITH THE HI RESULT WAS TAKEN AT 2:48 PM. CUSTOMER WAS TREATED WITH GLUCOSE AT THE HOSP TO RAISE LEVELS. TESTING WAS CONDUCTED ON THE FINGERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA/OPTIUM BLOOD GLUCOSE METER LFR THERASENSE, INC. * 10706

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention