BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2488789 · Received March 12, 2012

    Report

    Report Number
    2122870-2012-00732
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    December 14, 2011
    Report Date
    February 15, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION SERVICE WAS DISPATCHED FOR THIS EVENT. SPECIFIC PATIENT SAMPLING DETAILS WERE NOT SUPPLIED BY THE CUSTOMER TO DATE. UPON REVIEW OF THE CUSTOMER SUPPLIED DATA, MULTIPLE ESTRADIOL QUALITY CONTROL (QC) FAILURES WERE OBSERVED. THE CUSTOMER INDICATED 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. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. 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, 2122870-2012-00711, 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, 2122870-2012-00670, 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, 2122870-2012-00703, 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

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED ERRATIC PATIENT AND QUALITY CONTROL (QC) ESTRADIOL RESULTS WERE GENERATED INVOLVING 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 RESULTS OBTAINED ON (B)(6) 2011 AND USING THE ESTRADIOL REAGENT LOT # 020425. 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 ERRATIC PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ESTRADIOL