BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 788113 · Received November 20, 2006

    Report

    Report Number
    2122870-2006-00251
    Event Type
    Other
    Date Received
    November 20, 2006
    Date of Event
    October 24, 2006
    Report Date
    November 20, 2006
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS. SYSTEM CHECK PERFORMED ON 10/25/2006 WAS WITHIN SPECIFICATIONS. THE CUSTOMER CONDUCTED CARRYOVER TESTING ON 10/25/2006 WHICH PASSED. THE SPECIMENS WERE COLLECTED IN BD, 13X75, LITHIUM HEPARIN TUBES AND CENTRIFUGED AT 2,387 RPM FOR 10 MINUTES. THE CUSTOMER REPORTED LATENT FIBRIN IN SAMPLE A THAT WAS PULLED FROM THE REFRIGERATOR FOR REPEAT TESTING. BASED ON AVAILABLE INFORMATION, SAMPLE A SAT FOR 2 HOURS BEFORE BEING CENTRIFUGED. A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER'S LAB ON 10/27/06. THE FSE CONDUCTED DIAGNOSTIC, CARRYOVER AND PRECISION TESTING; ALL RESULTS WERE WITHIN SPECIFICATIONS. THE FSE VERIFIED THE INSTRUMENT PER ESTABLISHED PROCEDURES. THE ACCU TNI RESULTS OBTAINED IN THIS EVENT WERE WITHIN THE RISK STRATIFICATION RANGE AND BELOW THE AMI CUT-OFF VALUE OF 0.50NG/ML. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED IN THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THE REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT THAT WAS GENERATED BY THE UNICEL DXL 800 ACCESS INSTRUMENT. A PATIENT SAMPLE (A) WAS TESTED FOR ACCU TNI AND AN INITIAL RESULT WAS 0.46 NG/ML AND 0.47NG/ML UPON REPEAT. THE RESULT OF 0.47NG/ML WAS REPORTED OUT OF THE LAB AND QUESTIONED BY A PHYSICIAN. ON THE SAME DAY, THE CUSTOMER COLLECTED A FRESH SAMPLE (B) FROM THE PATIENT AND TESTED FOR ACCU TNI; THE RESULT WAS 0.03NG/ML. THE CUSTOMER PULLED SAMPLE A FROM REFRIGERATOR ON THE NEXT DAY AND RETESTED FOR ACCU TNI; THE REPEATED RESULT WAS 0.09NG/ML. IN ADDITION, SAMPLE A WAS TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB FOR ACCU TNI AND A RESULT OF 0.12NG/ML WAS OBTAINED. THE CUSTOMER ALSO INDICATED THAT A SAMPLE FROM THIS PATIENT COLLECTED AND TESTED A DAY BEFORE THE EVENT RECOVERED AS "<0.03NG/ML." BASED ON AVAILABLE INFORMATION, THE PATIENT WAS ADMITTED AND TREATED WITH AN ANTICOAGULANT THERAPY DUE TO THE ERRONEOUS RESULT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA