BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 958982 · Received December 4, 2007

    Report

    Report Number
    2122870-2007-00281
    Event Type
    Malfunction
    Date Received
    December 4, 2007
    Date of Event
    November 3, 2007
    Report Date
    December 4, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, QC WAS WITHIN SPECS ON THE DATES OF THE EVENT. HOWEVER, DATA PROVIDED FROM 11/15/07 SHOWED THAT THERE WAS A QC FAILED ERROR, BUT CUSTOMER RE-RAN QC AND RESULTS WERE WITHIN SPECS. THE SPECIMENS WERE COLLECTED IN BD, PLASTIC 4ML, LITHIUM HEPARIN TUBES WITH GEL SEPARATORS AND WERE CENTRIFUGED AT 2,800 RPM WITHIN ONE HOUR OF COLLECTION. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: A) THE FSE PERFORMED A TYPE I PROTOCOL VERIFICATION TESTING AND VERIFIED THE INSTRUMENT PERFORMANCE PER ESTABLISHED PROCEDURES. B) THE FSE DISCUSSED PRE-ANALYTICAL SAMPLE HANDLING ISSUES WITH THE CUSTOMER. IN A F/U WITH THE CUSTOMER IN LATE 2007, THEY STATED THAT AN INTERNAL STUDY WAS PREFORMED IN WHICH SAMPLES WERE RE-RUN AFTER RE-CENTRIFUGING THE SUPERNATANT VERSUS RERUNNING WITHOUT RE-CENTRIFUGATION. CUSTOMER CONCLUDED THAT SAMPLE RE-SPINNING HELPS TO GENERATE MORE RELIABLE RESULTS. A) CUSTOMER NOW HAS A PROTOCOL IN PLACE TO RE-CENTRIFUGE ANY QUESTIONABLE RESULTS BEFORE RERUNNING. 5. ALTHOUGH THE CUSTOMER STRONGLY AGREED THAT PRE-ANALYTICAL ISSUES COULD HAVE ADVERSELY AFFECTED THE RESULTS, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING ERRONEOUS TROPONIN (ACCU TNI) RESULTS THAT WERE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TWO (2) PT SAMPLES. PT A: AN INITIAL ACCU TNI RESULT WAS 1.39 NG/ML. THE SAMPLE WAS REFLEXED AND A RESULT OF 0.96NG/ML WAS REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLE WAS RE-TESTED 2 MORE TIMES AND RESULTS WERE: 0.33NG/ML, 0.25NG/ML. CUSTOMER THEN RE-SPUN THE ORIGINAL SAMPLE AND RETESTED ONCE MORE, AND ACCU TNI RESULT WAS 0.10NG/ML. IN ADDITION, THE SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND A RESULT OF 0.25 NG/ML WAS OBTAINED. THE SAMPLE WAS RETESTED AND AN ACCU TNI RESULT WAS 0.24 NG/ML. A CORRECTED REPORT HAS BEEN SUBMITTED. PT B: AN INITIAL ACCU TNI RESULT WAS 1.16NG/ML AND 0.07NG/ML UPON REPEAT. THE REPEATED RESULT WAS REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT ATTRIBUTED TO 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 YR