BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROSET ANALYZER

    MDR report key: 1252303 · Received December 8, 2008

    Report

    Report Number
    1628664-2008-00276
    Event Type
    Malfunction
    Date Received
    December 8, 2008
    Report Date
    November 26, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ISSUE WAS RESOLVED ON SITE BY AN ABBOTT FIELD SERVICE REPLACEMENT OF THE DAMAGED / CRASHED AEROSET SAMPLE PROBE AND THE ASSOCIATED TUBING. SUBSEQUENT VERIFICATION TESTING COMPRISED OF PRECISION AND CONTROL RUNS PASSED. THE CUSTOMER'S ISSUE IS ADDRESSED IN THE AEROSET SYSTEM OPERATIONS MANUAL (LIST NUMBER 09D06-05 ;(B)(4) 2004), OPERATIONAL PRECAUTIONS AND LIMITATIONS, GENERAL PRECAUTIONS, SERVICE AND MAINTENANCE, TROUBLESHOOTING AND DIAGNOSTICS, OBSERVED PROBLEMS, RESULTS ARE ERRATIC, PRECISION IS POOR. A MALFUNCTION OF THE AEROSET ANALYZER WAS IDENTIFIED. THE INVESTIGATION INDICATED THE ERRATIC PATIENT RESULTS WERE CAUSED BY A DAMAGED/CRASHED SAMPLE PROBE. ABBOTT FIELD SERVICE RESOLVED THE ISSUE ON SITE THROUGH REPLACEMENT OF THE DAMAGED SAMPLE PROBE AND THE ASSOCIATED TUBING. NO SUBSEQUENT COMPLAINTS AGAINST AEROSET (B)(4) HAVE BEEN DOCUMENTED SINCE THIS ISSUE WAS RESOLVED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE AEROSET ANALYZER GENERATED AN INITIAL CREATINE KINASE (CK) RESULT OF <7 U/L THAT RETESTED AT 1200 U/L. A SERVICE CALL WAS INITIATED. NO FURTHER INFORMATION IS AVAILABLE. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CC CREATINE KINASE LN: 7D63| CC CREATINE KINASE LN: 7D63