BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 3110251 · Received May 13, 2013

    Report

    Report Number
    2122870-2013-00448
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, CALIBRATION PASSED WITH ACCEPTABLE RELATIVE LIGHT UNIT VALUES, PERCENT COEFFICIENT OF VARIATION (%CV) AND PRECISION. ON (B)(6) 2013, QUALITY CONTROL (QC) LEVEL 2 WAS OUT OF RANGE HIGH BUT WAS WITHIN RANGE AFTER A RERUN. QC LEVEL 1 WAS WITHIN RANGE. ON (B)(6) 2013, QC LEVEL 1 WAS OUT OF RANGE HIGH BUT WAS WITHIN RANGE AFTER A RERUN. QC LEVEL 2 WAS WITHIN RANGE. THE FIELD SERVICE ENGINEER (FSE) DISCOVERED DISPENSE PROBE #3 WAS LOOSE AND NOT SECURED TO THE PROBE HOLDER. THE FSE TIGHTENED AND SECURED DISPENSE PROBE #3 SCREW TO ITS HOLDER AND RESOLVED THE ISSUE. THE FSE NOTED SYSTEM CHECK WAS WITHIN SPECIFICATIONS PRIOR TO SERVICE. THE FSE VERIFIED SYSTEM CHECK AND QUALITY CONTROL WERE WITHIN THE ACCEPTABLE LIMITS. NO FURTHER ISSUES WERE NOTED. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. DISPENSE PROBE #3 IS NOT PART OF REGULAR CUSTOMER PERFORMED MAINTENANCE. THE CAUSE OF THE LOOSE DISPENSE PROBE #3 IS UNKNOWN. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2013-00440, 2122870-2013-00448, 2122870-2013-00449.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, FOR FOUR PATIENTS, INVOLVING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH THE ACCESS ACCUTNI ASSAY AND CALIBRATOR. ONE PATIENT'S SAMPLE PRODUCED AN INITIAL RESULT OF 0.12 UG/L. THE SAME PATIENT SAMPLE WAS REANALYZED AND RECOVERED RESULTS OF 0.0001 UG/L AND 0.004 UG/L. SUBSEQUENT ANALYSES OF THE OTHER THREE PATIENTS' SAMPLES RECOVERED NEGATIVE TROPONIN I RESULTS ACTUAL VALUES WERE NOT SUPPLIED. THE CUSTOMER STATED ALL FOUR ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE CARDIOLOGIST AS THE VALUES DID NOT FIT THE PATIENTS' CLINICAL STATUS. TWO PATIENTS WERE ADMITTED TO THE HOSPITAL AND RECEIVED ANTI-CLOTTING TREATMENT BASED ON THE ERRONEOUS VALUES. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. THE CUSTOMER INDICATED QUALITY CONTROL WAS WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THIS IS REPORT TWO OF THREE REPRESENTING ONE OF THE TWO PATIENTS THAT HAD MEDICAL INTERVENTION ON THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210200 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O