BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1033187 · Received April 23, 2008

    Report

    Report Number
    2122870-2008-00131
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 6, 2008
    Report Date
    April 23, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS ON THE DATE OF THE EVENT. A SYSTEM CHECK PERFORMED A WEEK PRIOR FAILED PARTIALLY AND PASSED UPON REPEAT. THE SPECIMEN WAS COLLECTED INTO A LITHIUM HEPARIN TUBE AND WAS CENTRIFUGED AT 3,000 RPM FOR 6 MINUTES. A FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE PERFORMED A DIAGNOSTIC TESTING WHICH FAILED. THE FSE REPLACED ASPIRATE PROBE PERI-PUMP TUBING AND THEN REPEATED THE DIAGNOSTIC TESTING WITH GOOD RESULTS. THE FSE CONDUCTED A CARRYOVER TESTING WHICH FAILED. THE FSE ALIGNED SAMPLE PROBE AND REPEATED THE CARRYOVER TESTING AND OBTAINED PASSING RESULTS. THE FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES. ALTHOUGH THE FSE NOTED HARDWARE ISSUES, PRE-ANALYTICAL FACTORS MAY HAVE ALSO CONTRIBUTED TO THIS EVENT. HOWEVER, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) REGARDING AN ERRONEOUSLY HIGH TROPONIN (ACCU TNI) RESULT GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. A PT SAMPLE WAS TESTED FOR ACCU TNI AND A RESULT OF 17.35NG/DL WAS OBTAINED INITIALLY AND 0.64NG/ML UPON REPEAT. THE SAMPLE WAS RE-CENTRIFUGED AND THEN RETESTED FOR ACCU TNI, AND A RESULT OF 0.10NG/ML WAS REPORTED OUT OF THE LAB. THE RE-CENTRIFUGED SAMPLE WAS RETESTED ONCE MORE AND A RESULT OF 0.09NG/ML WAS OBTAINED. THE ERRONEOUSLY ELEVATED RESULT WAS NOT REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA