BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1365530 · Received January 16, 2009

    Report

    Report Number
    2122870-2009-00013
    Event Type
    Malfunction
    Date Received
    January 16, 2009
    Date of Event
    December 29, 2008
    Report Date
    January 16, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED IN PLASTIC, BD SODIUM HEPARIN TUBES AND WERE CENTRIFUGED AT 3,500 RPM FOR 5 MINUTES. THE SAMPLES WERE REMOVED FROM THE ORIGINAL TUBES, PLACED IN 12X75 PLASTIC TUBES, MIXED, AND RE-SPUN PRIOR TO REPEAT ANALYSIS. QC RESULTED WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK PERFORMED IN LATE 2008, RESULTED WITHIN SPECIFICATIONS. THERE WERE NO EVENTS POSTED TO THE EVENT LOG AT THE TIME OF THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE RAN A DIAGNOSTIC TESTING AND A LEVEL I ACCU TNI QC PRECISION TESTING ACROSS ALL FOUR PIPETTORS, WHICH ALL RESULTED WITHIN SPECIFICATIONS AND CORRELATED WITH THE DIFFERENT INSTRUMENT. THE FSE RECOMMENDED THE CUSTOMER CHANGE CENTRIFUGE TIME FROM 5 TO 10 MINUTES AND ALSO SET-UP REFLEX TESTING FOR VALUES >0.15NG/ML. THE FSE NOTED IN A DIFFERENT CF THAT HE OBSERVED "DEBRIS" IN SOME PATIENT SAMPLES. NO DETAILS REGARDING WHICH PATIENT SAMPLES CONTAINED THIS WERE SUPPLIED. THE FSE ALSO RECOMMENDED THE CUSTOMER DISCONTINUE AUTO-VERIFICATION OF ELEVATED ACCUTNI RESULTS TO FIRST DETERMINE IF THE FLIERS ARE DUE TO PRE-ANALYTICAL SPECIMEN HANDLING. THE FSE NOTED THAT THE EVENT APPEARS TO BE DUE TO PRE-ANALYTICAL FACTORS. THE FSE VERIFIED REPAIR, PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. BCI CONTACTED THE LAB TO FOLLOW-UP ON THIS EVENT AND CUSTOMER STATED THEY ARE REPEATING SLIGHTLY ELEVATED ACCU TNI SAMPLES, AND THEY WILL CONTACT BCI IF FURTHER ASSISTANCE IS REQUIRED. PRE-ANALYTICAL SAMPLE HANDLING MAY HAVE CONTRIBUTED TO THIS EVENT; HOWEVER, A DEFINITIVE 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 ERRONEOUSLY HIGH TROPONIN (ACCU TNI) RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TWO PATIENT SAMPLES. PATIENT A: THE INITIAL RESULT WAS 0.23NG/ML AND 0.56NG/ML UPON REPEAT. THE SAMPLE WAS TESTED FOR ACCU TNI ON A DIFFERENT INSTRUMENT AND A RESULT OF 0.02NG/ML WAS OBTAINED. ON THE NEXT DAY, THE SPECIMEN WAS MIXED AND RE-SPUN AND THEN RE-TESTED ON THE UNICEL DXI 800 INSTRUMENT AND ON THE DIFFERENT INSTRUMENT AND RESULTS WERE: 0.23NG/ML AND 0.02NG/ML RESPECTIVELY. PATIENT B: THE INITIAL RESULT WAS 0.57NG/ML AND 0.03NG/ML WHEN THE SAMPLE WAS REPEATED. THE SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT AND AN ACCU TNI RESULT WAS 0.01NG/ML. THE SPECIMEN WAS MIXED AND RESPUN, AND THEN RE-TESTED ON THE UNICEL DXI 800 INSTRUMENT AND ON THE DIFFERENT INSTRUMENT AND RESULTS WERE: 0.22NG/ML AND 0.00NG/ML RESPECTIVELY. THE RESULTS WERE REPORTED OUT OF THE LAB. BOTH PATIENTS UNDERWENT CT ANGIOGRAMS, WHICH BOTH RESULTED NEGATIVE, PER CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA