BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1001712 · Received February 15, 2008

    Report

    Report Number
    2122870-2008-00047
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 26, 2008
    Report Date
    February 15, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS ON THE DAY OF THE EVENT. A SYSTEM CHECK PERFORMED ON 01/19/08 PASSED. THE SPECIMEN WAS COLLECTED IN BD, LITHIUM HEPARIN TUBE WITH GEL AND WAS CENTRIFUGED AT 3,000 RPM FOR 9 MINS. THE CUSTOMER RAN AN ACCU TNI PT SAMPLE FOR PRECISION TESTING IN 2008 AND OBTAINED GOOD RESULTS. A FIELD SERVICE ENGINEER (FSE) CONTACTED THE LAB ON ELEVEN DAYS LATER AND ASSISTED THE CUSTOMER VIA TELEPHONE. DATA WAS REVIEWED AND PRECISION TESTING WAS PERFORMED ON REAGENTS PACKS WITH ACCEPTABLE RESULTS. BASED ON AVAIL INFO, SERVICE WAS ON SITE THE PREVIOUS WEEK AND PERFORMED A PREVENTIVE MAINTENANCE (PM) ON THE ANALYZER. PER FSE, CUSTOMER AGREED THE ERRONEOUS RESULT WAS VERY LIKELY DUE TO SAMPLE HANDLING. ALTHOUGH PRE-ANALYTICAL SAMPLE HANDLING MAY HAVE CONTRIBUTED TO THIS EVENT, A CLEAR ROOT CAUSE FOR THIS EVENT 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 THAT WAS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR A SINGLE PT SAMPLE. A PT SAMPLE WAS TESTED FOR ACCU TNI AND A RESULT OF 1.75NG/ML WAS OBTAINED. THE RESULT WAS REPORTED OUT OF THE LAB. THE SAMPLE WAS RE-SPUN AND THEN RE-TESTED FOR ACCU TNI SEVERAL TIMES. ACCU TNI REPEATED RESULTS WERE IN THE RANE OF 0.04NG/ML-0.07NG/ML. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA