BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTACT/SOFT-SENSE

    MDR report key: 576017 · Received February 24, 2005

    Report

    Report Number
    2954323-2005-00054
    Event Type
    Injury
    Date Received
    February 24, 2005
    Date of Event
    February 8, 2005
    Manufacturer
    THERASENSE, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REVIEW OF COMPLAINT INFORMATION REPORTED THAT A CUSTOMER WAS RECEIVING HIGH READINGS ON A SOF-TACT METER. THE CUSTOMER HAD BEEN FEELING UNWELL FOR A COUPLE OF DAYS. THE CUSTOMER PERFORMED A GLUCOSE TEST AND THE TEST WAS FINE. AS THE CUSTOMER WAS STILL FEELING UNWELL, A DOCTOR WAS CALLED AND THE CUSTOMER WAS GIVEN A GLUCOSE SOLUTION. THE HOSPITAL PERFORMED SEVERAL COMPARISON TESTS WITH THE CUSTOMER'S METER AND THE OPTIUM METER. THE HOSPITAL READINGS WERE 197, 162, 231, AND 205 MG/DL COMPARED TO THE OPTIUM READINGS OF 154, 129, 142, AND 142 MG/DL. THE CUSTOMER WAS HOSPITALIZED DUE TO AN ULCER DISCOVERED DURING A CHECK UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTACT/SOFT-SENSE BLOOD GLUCOSE METER CFR THERASENSE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization