BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 236937 · Received August 19, 1999

    Report

    Report Number
    1628664-1999-00045
    Event Type
    Malfunction
    Date Received
    August 19, 1999
    Date of Event
    July 23, 1999
    Report Date
    August 18, 1999
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON 7/23/1999 CUSTOMER REPORTED A "BHCG" RESULT OF 6600MLU/ML FROM A 1:200 DILIUTION. SAMPLE WAS REPEATED ON 7/24/1999 AND A RESULT OF 18,000MLU/ML WAS OBTAINED. ON 7/25/1999 SAMPLE WAS SENT TO ANOTHER SITE TO BE RUN TO THEIR AXSYM, A RESULT OF 18,405 WAS PRODUCED. NO TREATMENT WAS GIVEN, NO REPORT OF INJURY OR IMPACT TO PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR AXSYM BHCG REAGENT LIST 7A59 LOT # 52158Q100.