BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMX ANALYZER

    MDR report key: 187359 · Received September 11, 1998

    Report

    Report Number
    1628664-1998-00079
    Event Type
    Other
    Date Received
    September 11, 1998
    Date of Event
    August 12, 1998
    Report Date
    September 10, 1998
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    LCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 08/12/1998 THE ACCOUNT REPORTED A BHCG RESULT OF 2688 MIU/ML FOR A SAMPLE TESTED WITH "IMX" BHCG" REAGENT LIST NUMBER 1A06-20. THE ACCOUNT RETESTED THE SAMPLE WITH "IMX BHCG" REAGENT LIST NUMBER 1A06-22 AND OBTAINED RESULTS OF 6090/5728 MIU/ML. THE SAMPLE WAS RETESTED WITH IMX BHCG" REAGENT LIST NUMBER 1A06-20 AND A RESULT OF 2748 MIU/ML WAS OBTAINED. ALL TESTING WAS PERFORMED WITH THE AUTOMATED 1:200 DILUTION. THE CUSTOMER THEN SENT THE SAMPLE TO A REFERENCE LAB FOR TESTING AND A RESULT OF 19,089 MIU/ML WAS OBTAINED. ACCORDING TO THE ACCOUNT, AFTER SVC CHANGED THE WORN PUMP BELT ON THE INSTRUMENT, THE BHCG RESULTS CORRELATED BETWEEN BOTH "IMX" REAGENT LIST NUMBERS AND THE REFERENCE LAB METHODOLOGY. THE EXACT CONCENTRATIONS OBTAINED WERE NOT PROVIDED BY THE ACCOUNT. NO SAMPLE WAS AVAILABLE FROM THE REFERENCE LAB TO VERIFY TEST RESULTS AFTER MAINTENANCE PERFORMED. NO REPORT OF INJURY DUE TO THE INITIAL REPORTED RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMX ANALYZER AUTOMATED IMMUNOASSAY ANALYZER LCI ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR IMXB HCG REAGENTS, LIST NUMBERS| 1A06-20 AND 1A06-22.