BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 731518 · Received June 20, 2006

    Report

    Report Number
    2122870-2006-00139
    Event Type
    Other
    Date Received
    June 20, 2006
    Date of Event
    May 19, 2006
    Report Date
    June 20, 2006
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN CUSTOMER'S SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. SYSTEM CHECK PERFORMED ON 05/16/2006 PASSED. THE SPECIMEN WAS COLLECTED IN A PLAIN SERUM TUBE, ALLOWED TO CLOT AND THEN CENTRIFUGED IN A STAT SPIN CENTRIFUGE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER LAB. THE FSE REBUILT PRECISION PUMP, REPLACED TUBING AND BELT WHICH WAS SLIGHTLY SHREDDED. THE FSE REPLACED ASPIRATE PROBES. THE FSE RAN SYSTEM CHECK WHICH PASSED. THE FSE PERFORMED DIAGNOSTIC AND CK-MB PRECISION TESTING; THE RESULTS WERE WITHIN SPECIFICATIONS. THE FSE VERIFIED THAT THE INSTRUMENT IS OPERATING PER ESTABLISHED PROCEDURES. SAMPLE HANDLING WAS DISCUSSED WITH THE CUSTOMER. IN A FOLLOW-UP WITH THE CUSTOMER ON 06/05/06, THEY HAVE NOT SEEN FURTHER CK-MB ISSUES. THE CUSTOMER INDICATED THAT THEY BELIEVE THIS IS AN ISOLATED ISSUE RELATED TO A SINGLE PATIENT SAMPLE. PER BECKMAN COULTER PRODUCT LABELING: "CK-MB RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PATIENT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, DATA FROM ADDITIONAL TESTS AND OTHER APPROPRIATE INFORMATION." ALTHOUGH THE FSE NOTED AND ADDRESSED HARDWARE ISSUES, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED IN THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING AN ERRONEOUSLY ELEVATED CREATINE KINASE MB ISOENZYME (CK-MB) RESULT FROM A SINGLE PATIENT SAMPLE THAT WAS GENERATED BY THE SYNCHRON LX I 725 INSTRUMENT. THE CK-MB RESULT OF 18.3 NG/ML WAS REPORTED OUT OF THE LAB. THE PATIENT ORIGINAL SAMPLE WAS RE-TESTED FOR CK-MB APPROX 8 HOURS LATER. THE REPEATED CK-MB RESULT WAS 4.0 NG/ML. THE CUSTOMER RE-TESTED THE PATIENT SAMPLE FOR CK-MB A 2ND TIME AND OBTAINED RESULT OF 3.9 NG/ML. A FRESH SAMPLE WAS COLLECTED FROM THE PT AND TESTED FOR CK-MB; THE RESULT WAS 2.6 NG/ML. ALTHOUGH TOTAL CREATINE PHOSPHOKINASE (CPK) AND TROPONIN (ACCU TNI) RESULTS FOR THIS SAMPLE RECOVERED WITHIN NORMAL RANGES, THE PATIENT RECEIVED A CARDIAC CATHETERIZATION DUE TO THE INITIAL HIGH CK-MB RESULT. PER BECKMAN COULTER PRODUCT LABELING: "CK-MB RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PATIENT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, DATA FROM ADDITIONAL TESTS AND OTHER APPROPRIATE INFORMATION." THERE WAS NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX I 725 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA