BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 125223 · Received October 6, 1997

    Report

    Report Number
    1628664-1997-00083
    Event Type
    Other
    Date Received
    October 6, 1997
    Date of Event
    April 24, 1997
    Report Date
    October 3, 1997
    Manufacturer
    ABBOTT MFG., INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 04/24/1997, AT 04:18 AM, THE ACCOUNT REPORTED A DISCREPANT CK-MB RESULT OF 19.1 NG/ML, WHICH WAS RUN ON THE AXSYM ANALYZER. THE PATIENT'S TOTAL CPK WAS 70. THE SAMPLE WAS RETESTED AFTER THE ACCOUNT RECEIVED A CK-MB RESULT OF 9.6 NG/ML ON THE PATIENT AT 7:25 AM. ACCORDING TO THE ACCOUNT, THE PATIENT DID NOT RECEIVE TREATMENT BASED ON THE REPORTED DISCREPANT RESULT. THE CUSTOMER STATED THAT ALL CONTROLS WERE WITHIN EXPECTED RANGES. THERE WERE NO BUBBLES IN THE SPECIMEN AND IT WAS FREE OF FIBIN. REVIEW OF THE MESSAGE HISTORY LOG REVEALED A PROBE CRASH ON 4/17/1997 WITHOUT A PROBE CRASH RECOVERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR AXSYM CK-MB REAGENT, LIST NUMBER 7A57-20, LOT| NUMBER 25191Q200.