BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 146156 · Received January 27, 1998

    Report

    Report Number
    1628664-1998-00004
    Event Type
    Malfunction
    Date Received
    January 27, 1998
    Date of Event
    December 23, 1997
    Report Date
    January 23, 1998
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON 12/23/1997 THE ACCOUNT REPORTED AN ERRATIC CK-MB RESULT OF 16.4 NG/ML, WHICH WAS RUN ON THE AXSYM ANALYZER. THE PT WAS AN OUTPATIENT AND THE PHYSICIAN QUESTIONED THE RESULT. A NEW SAMPLE WAS COLLECTED ON 12/24/1997 AND GAVE A RESULT OF 2.2 NG/ML. THE PHYSICIAN NOTIFIED THE LAB OF THE ERRATIC RESULT FROM 12/23/1997 AND THE ORIGINAL SAMPLE WAS RETESTED, GIVING 1.8 NG/ML (12/26/1997), 1.5 AND 2.0 NG/ML (12/27/1997). ACCORDING TO THE ACCOUNT, THE ORIGINAL SAMPLE WAS THE ONLY SAMPLE RUNNING AT THE TIME OF THE INCIDENT. ALL CONTROLS WERE WITHIN THEIR SPECIFIED RANGES. NO TREATMENT WAS GIVEN BASED UPON THE FIRST REPORTED RESULT.

    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 54 YR AXSYM CK-MB REAGENT, 7A57-20, LOT 31339Q100.