BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM, RECONDITIONED

    MDR report key: 2489453 · Received March 13, 2012

    Report

    Report Number
    2122870-2012-00583
    Event Type
    Malfunction
    Date Received
    March 13, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 16, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT SAMPLING DETAILS WERE NOT SUPPLIED BY THE CUSTOMER TO DATE. BEC CUSTOMER ADVOCATE (CA) REVIEWED ALL THREE LEVELS OF THE CUSTOMER SUPPLIED ESTRADIOL QC CHARTS DATED (B)(4) 2012. ALL QC VALUES WERE WITHIN 1 TO 2 SD OF THE CUSTOMER'S ESTABLISHED MEANS PRIOR TO THE EVENT. HOWEVER, THE CUSTOMER OBTAINED ERRATIC ESTRADIOL QC RESULTS ON (B)(6) 2012. THE CUSTOMER NOTES THAT THE ERRATIC ESTRADIOL RESULTS OCCURRED AFTER SWITCHING TO THE NEW ESTRADIOL ANTIBODY (REAGENT LOT # 170077). BEC CUSTOMER ADVOCATE ALSO REVIEWED THE CUSTOMER SUPPLIED ESTRADIOL CALIBRATION CURVE FROM (B)(6) 2012. THE CALIBRATION CURVE WAS ACCEPTED AS PASSING AND HAD ACCEPTABLE %CVS (REAGENT LOT # 170077 AND CALIBRATOR LOT # 022270). HOWEVER, THE CALIBRATION'S RELATIVE LIGHT UNITS ARE LOWER THAN THE BEC RELEASED DATA BY APPROXIMATELY HALF. THE SYSTEM CHECK PERFORMED ON (B)(4) 2012 PASSED WITHIN THE SPECIFICATIONS. ADDITIONALLY, THE CUSTOMER PERFORMED THE WASHED PORTION OF SYSTEM CHECK ON (B)(4) 2012, AND THE RESULTS ALSO PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE CUSTOMER ROUTINELY PERFORMS SYSTEM MAINTENANCE ON TIME INCLUDING RUNNING SPECIAL CLEAN, CLEANING THE ASPIRATE PROBES AND CHANGING THE DUCK BILL VALVE. THERE IS NO INDICATION THAT A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT TO DATE. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Additional Manufacturer Narrative · 1

    A ROUTINE YEARLY MAINTENANCE WAS PERFORMED ON THE INSTRUMENT, AND NO FURTHER ISSUES HAVE BEEN REPORTED FROM THE CUSTOMER'S SITE.(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO OBTAINING ERRATIC PATIENT AND QUALITY CONTROL (QC) ESTRADIOL RESULTS THAT WERE GENERATED BY UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM USING ACCESS ESTRADIOL REAGENTS LOT # 170077. UPON REPEAT ON THE SAME INSTRUMENT, DIFFERENT RESULTS WERE GENERATED OUTSIDE OF THE ASSAY'S STATED PRECISION CLAIM OF LESS THAN OR EQUAL TO 12%. THE QUESTIONED PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN IF THERE WERE ANY CHANGES TO PATIENT TREATMENT. THERE HAS BEEN NO REPORT OF DEATH OR INJURY ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1