BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX®I 725 SYSTEM

    MDR report key: 2519222 · Received April 5, 2012

    Report

    Report Number
    2122870-2012-00975
    Event Type
    Malfunction
    Date Received
    April 5, 2012
    Date of Event
    March 14, 2012
    Report Date
    March 14, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    Z-0607-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE ISSUE WAS RESOLVED ON SITE, AND THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THE CAUSE OF THE INCIDENT IS DUE TO OPERATOR ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SEVEN CREATINE KINASE-MB (CK-MB) PATIENT TEST RESULTS WERE GENERATED FROM A SHARED REAGENT PACK INVOLVING SYNCHRON LXI 725 SYSTEM. DURING INSTRUMENT INSTALLATION, BECKMAN COULTER FIELD APPLICATIONS SPECIALIST DISCOVERED THE CUSTOMER HAD REMOVED THE CK-MB REAGENT PACK FROM THE INSTALLED UNIT AND PLACED IT IN THE SYNCHRON LXI 725 SYSTEM DUE TO THE CUSTOMER WAS OUT OF REAGENT PACKS. THE QUESTIONED PATIENT RESULTS WERE RELEASED OUT OF THE LABORATORY. SUBSEQUENT TESTING OF THE SEVEN PATIENT SAMPLES, WITH A NEW REAGENT PACK, RECOVERED REPRODUCIBLE RESULTS COMPARED TO THE INITIAL VALUES OBTAINED FROM THE SHARED REAGENT PACK. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED THE YELLOW LABEL, WARNING AGAINST REAGENT PACK SHARING, WAS CLEARLY DISPLAYED ON THE UNIT. BECKMAN COULTER, INC. DISCUSSED THE IMPORTANCE OF NOT SHARING REAGENT PACKS BETWEEN SYSTEMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS CK-MB CALIBRATORS| ACCESS CK-MB