BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM.

    MDR report key: 1930953 · Received December 17, 2010

    Report

    Report Number
    2122870-2010-00946
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE TUBE WAS CENTRIFUGED AT THE OFFSITE CLINIC AND WAS NOT RE-CENTRIFUGED BEFORE TESTING. INITIAL RESULT AND FIRST RERUN WERE FROM THE ORIGINAL SAMPLE TUBE. FOR THE SECOND RERUN, SAMPLE WAS ALIQUOTED INTO A SAMPLE CUP BEFORE RERUNNING. PER THE CUSTOMER, QC IS RECOVERING WITHIN ESTABLISHED RANGES. A SYSTEM CHECK RUN AFTER THE EVENT PASSED ALL SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2010. THE FSE NOTED THAT THE CUSTOMER HAD AN ISSUE WITH A CLOTTED SAMPLE PRIOR TO ARRIVAL FOR HARDWARE VERIFICATION. CUSTOMER HAD REPLACED ASPIRATE PROBES. THE FSE REVIEWED INSTRUMENT AND FOUND NO OBVIOUS HARDWARE PROBLEMS. THE FSE RAN HIGH SENSITIVITY (HS) SYSTEM CHECK AND QC WHICH PASSED. THE FSE NOTED THAT PREVENTATIVE MAINTENANCE (PM) WAS PERFORMED WITHIN THE LAST 60 DAYS. THE CUSTOMER STATED THAT IT IS BELIEVED THAT THE TROPONIN RESULT WAS DUE TO A "SAMPLE ISSUE". ALTHOUGH NO CLEAR ROOT CAUSE COULD BE DEFINITIVELY DETERMINED, PRE-ANALYTICAL SAMPLE HANDLING IS THE SUSPECTED ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT, IN THE RISK STRATIFICATION RANGE, FOR ONE PATIENT THAT WAS GENERATED BY THE UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM. UPON REPEAT, THE RESULT WAS IN THE NORMAL REFERENCE RANGE AND AN AMENDED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT AS THE RESULT WAS CORRECTED BEFORE THE PHYSICIAN HAD REVIEWED THE ORIGINAL ERRONEOUS RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM. DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1