BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2252937 · Received September 9, 2011

    Report

    Report Number
    2122870-2011-03553
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    March 30, 2010
    Report Date
    March 30, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    Z-1318-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN PLASTIC LITHIUM HEPARIN PLASMA TUBES WITH A GEL SEPARATOR. SAMPLES WERE CENTRIFUGED SAMPLES FOR THREE MINUTES IN A STATSPIN CENTRIFUGE; EXACT SPEED WAS NOT PROVIDED. ACCUTNI QUALITY CONTROL (QC) WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT AT APPROXIMATELY 01:00 ON (B)(6) 2010. THE CUSTOMER RERAN ACCUTNI QC AFTER THE EVENT AT APPROXIMATELY 20:00 AND IT FAILED. SPECIFIC QC DATA WAS NOT PROVIDED. THE CUSTOMER ATTEMPTED TO RECALIBRATE THE ACCUTNI ASSAY AND THE CALIBRATION FAILED AS WELL. CALIBRATION DATA WAS NOT PROVIDED. THE CUSTOMER PERFORMED A ROUTINE SYSTEM CHECK ON (B)(6) 2010 WHICH FAILED WITH A HIGH SUBSTRATE MEAN AND WASH %CV (COEFFICIENT OF VARIATION). ON (B)(6) 2010, THE FIELD SERVICE ENGINEER DETERMINED THAT THE INSTRUMENT WAS GENERATING ELEVATED SUBSTRATE RLU (RELATIVE LIGHT UNITS) AT 9500 (INSTRUMENT SPECIFICATION IS <9000). PERFORMED A SUBSTRATE DECONTAMINATION PROCEDURE AND VERIFIED THE RESULTS; SUBSTRATE RLUS WERE THEN WITHIN INSTRUMENT SPECIFICATIONS. REPLACED THE PERI-PUMP AND LIBRICATED ALL RAILS. PERFORMED A ROUTINE SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. RECALIBRATED ALL ASSAYS AND PERFORMED QC; NO ISSUES WERE NOTED. ROOT CAUSE WAS NOT DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. ON (B)(6) 2010, A BECKMAN COULTER, INC. EMPLOYEE SPOKE TO THE CUSTOMER REGARDING THE INVESTIGATION AND EVENT. THE CUSTOMER NOTES THAT THEY ARE RUNNING ALL TROPONINS IN DUPLICATE AND ALSO RUNNING THEM ON ANOTHER INSTRUMENT. THE ASSAY IS STILL NOT PERFORMING WELL. THE BCI EMPLOYEE REITERATED TO CUSTOMER THAT THE ASSAY SHOULD NOT BE RUN ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM PER (B)(4). THE CUSTOMER UNDERSTOOD AND WILL CONTINUE TO MONITOR THE ASSAY. NO ADDITIONAL ASSISTANCE WAS REQUESTED AT THIS TIME. THIS MDR REPRESENTS EVENT 50 OF 50 REPORTED BY THIS CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS HIGH ACCU TNI (TROPONIN I) TEST RESULTS WERE OBTAINED FOR 50 PT SAMPLES TESTED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER STATED THERE WERE MULTIPLE PT TEST RESULTS ABOVE NORMAL RANGE OF 0.04 NG/ML AND BELOW THE AMI (ACUTE MYOCARDIAL INFARCTION) CUTOFF = 0.50 NG/ML, I.E. 0.05-0.49 NG/ML. WHEN THE SAMPLE WERE REPEATED ON THE OTHER UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, RESULTS WERE IN THE NORMAL RANGE (<0.04 NG/ML). THE ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. THE TEST RESULTS WERE QUESTIONED. SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THE INITIAL ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. WHILE THERE IS NO REPORT OF ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNKNOWN WHETHER THERE WAS A CHANGE TO PATIENT MANAGEMENT. THIS IS EVENT 50 OF 50 FOR THE 50 PT SAMPLES INVOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCU TNI