BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROSET ANALYZER

    MDR report key: 526239 · Received February 18, 2004

    Report

    Report Number
    1628664-2004-00011
    Event Type
    Malfunction
    Date Received
    February 18, 2004
    Date of Event
    January 19, 2004
    Report Date
    February 17, 2004
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN QUESTIONED A PT'S AEROSET ANALYZER ASSAY RESULTS. THE PHYSICIAN'S CONCERN AROSE AFTER HAVING ANOTHER SAMPLE DRAWN ON THE PT WITH TEST RESULTS NOT CORRELATING WITH THE INITIAL RESULTS. THE INITIAL SAMPLE WAS RETRIEVED BY THE LAB FROM STORAGE AND RETESTED WITH RESULTS NOT CORRELATING WITH THE INITIAL RESULTS. THE CUSTOMER CLAIMS THAT THE AEROSET ANALYZER ASPIRATED FROM THE SAME SAMPLE TUBE 5 TIMES AND ASSIGNED SUBSEQUENT RESULTS TO 5 DIFFERENT SAMPLE (IDENTIFICATION) REPORTS. THE RESULTS WERE REPORTED FROM THE LAB. THERE IS NOT IMPACT TO PT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO AEROSET ANALYZER LIST NO. 9D05-1.| BOTH ANALYZERS USING SOFTWARE VERSION 1.02.