BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 279011 · Received May 19, 2000

    Report

    Report Number
    1628664-2000-00030
    Event Type
    Other
    Date Received
    May 19, 2000
    Date of Event
    April 17, 2000
    Report Date
    May 17, 2000
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON APRIL 17, 2000, THE CUSTOMER GENERATED AN AXSYM BETA-HUMAN CHORIONIC GONADOTROPIN VALUE OF >200,000MIU/ML FOLLOWING A 1:200 DILUTION. THE ACCOUNT THEN PERFORMED A 1:100 MANUAL DILUTION AND RAN THE SAMPLE AT A 1:200 AUTODILUTION, GIVING A RESULT OF 183,000 (CORRECTED FOR DILUTION, 18,300,000MIU/ML). THIS VALUE WAS REPORTED AND WAS NOT QUESTIONED BY A PHYSICIAN. BECAUSE THE VALUE WAS HIGHER THAN EXPECTED, THE SAMPLE WAS RE-RUN ON ANOTHER AXSYM INSTRUMENT AT A 1:200 DILUTION AND YIELDED A VALUE OF 55,000MIU/ML. ACCOUNT STATED CORRECTED VALUE WAS REPORTED IMMEDIATELY. ACCOUNT STATED THERE WAS NO IMPACT ON PT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM MEIA FOR MEASUREMENT OF TOTAL BHCG JJE ABBOTT MFG, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO AXSYM BHCG ASSAY.