BEUDAMED
    FDA Adverse Event Other Summary report: N

    TDXFLX SYSTEM

    MDR report key: 187244 · Received September 11, 1998

    Report

    Report Number
    1628664-1998-00081
    Event Type
    Other
    Date Received
    September 11, 1998
    Date of Event
    August 14, 1998
    Report Date
    September 10, 1998
    Manufacturer
    ABBOTT MFG., INC.
    Product Code
    LCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON OR AROUND 8/14/98, AN ERROR CODE "SAMPLE LEVEL HI" WAS PRINTED ON THE DATA TAPE WHEN AN AMNIOTIC FLUID SAMPLE WAS INITIALLY TESTED FOR TDXFLX FLM II. THE OPERATOR REPORTED THE RESULT AS "HI." THE INITIAL TESTING WAS PERFORMED ON A FRESH SAMPLE. THE SAMPLE WAS RETESTED GIVING A RESULT OF 16.0 MG/G. THE RETEST WAS PERFORMED ON A FROZEN SAMPLE. ACCORDING TO THE ACCOUNT, THE MOTHER WENT INTO LABOR AND THE CLINICIAN WAS UNABLE TO STOP IT. NO FURTHER INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TDXFLX SYSTEM AUTOMATED FPIA ANALYZER LCQ ABBOTT MFG., INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other TDXFLX FLM II REAGENT, LIST NUMBER 7A76.