BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL¿ DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2488768 · Received March 12, 2012

    Report

    Report Number
    2122870-2012-00745
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 15, 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
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT SAMPLING DETAILS WERE NOT SUPPLIED BY THE CUSTOMER TO DATE. UPON REVIEW OF THE CUSTOMER SUPPLIED DATA, MULTIPLE ESTRADIOL QC FAILURES WERE OBSERVED. THE CUSTOMER INDICATED THAT ERRATIC LEVEL 1 ESTRADIOL QC RESULTS OCCURRED AFTER SWITCHING TO A NEW ESTRADIOL REAGENT LOT # 170077. THE CUSTOMER ALSO EXPERIENCED FAILED QC RESULTS WITH ESTRADIOL REAGENT LOT # 170068. 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. THE FOLLOWING MDRS (TOTAL COUNT: 55) LISTED BELOW INCLUDES THE COMPLETE LIST OF REPORTS SUBMITTED FOR THIS EVENT THAT OCCURRED AT THIS CUSTOMER SITE: 2122870-2012-00669, 2122870-2012-00670, 2122870-2012-00671, 2122870-2012-00672, 2122870-2012-00673, 2122870-2012-00674, 2122870-2012-00676, 2122870-2012-00678, 2122870-2012-00679, 2122870-2012-00681, 2122870-2012-00683, 2122870-2012-00685, 2122870-2012-00711, 2122870-2012-00717, 2122870-2012-00721, 2122870-2012-00723, 2122870-2012-00724, 2122870-2012-00725, 2122870-2012-00726, 2122870-2012-00727, 2122870-2012-00728, 2122870-2012-00729, 2122870-2012-00730, 2122870-2012-00703, 2122870-2012-00704, 2122870-2012-00706, 2122870-2012-00707, 2122870-2012-00709, 2122870-2012-00710, 2122870-2012-00713, 2122870-2012-00714, 2122870-2012-00716, 2122870-2012-00718, 2122870-2012-00719, 2122870-2012-00722, 2122870-2012-00731, 2122870-2012-00732, 2122870-2012-00733, 2122870-2012-00734, 2122870-2012-00735, 2122870-2012-00736, 2122870-2012-00737, 2122870-2012-00738, 2122870-2012-00739, 2122870-2012-00740, 2122870-2012-00741, 2122870-2012-00742, 2122870-2012-00743, 2122870-2012-00744, 2122870-2012-00745, 2122870-2012-00748, 2122870-2012-00749, 2122870-2012-00750, 2122870-2012-00751, 2122870-2012-00752.

    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 ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, USED IN CONJUNCTION WITH THREE DIFFERENT ACCESS ESTRADIOL REAGENTS (LOT #S 020425, 170068, AND 170077). THIS EVENT OCCURRED OVER THE COURSE OF SEVERAL DAYS, BETWEEN (B)(6) 2011 AND (B)(6) 2012. THIS REPORT DOCUMENTS THE RESULT OBTAINED ON (B)(6) 2012 AND USING THE ESTRADIOL REAGENT LOT # 170077. UPON REPEAT ON THE SAME INSTRUMENT A DIFFERENT RESULT WAS GENERATED OUTSIDE OF THE ASSAY'S STATED PRECISION CLAIM OF LESS THAN OR EQUAL TO 12%. THE QUESTIONED PATIENT RESULT WAS NOT REPORTED OUT OF THE LABORATORY. NO DEATH OR INJURY ASSOCIATED WITH THIS EVENT AND PATIENT TREATMENT WAS NOT IMPACTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1