BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3133891 · Received May 29, 2013

    Report

    Report Number
    2122870-2013-00491
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH SYSTEM TROUBLESHOOTING VIA THE TELEPHONE. ALL LEVELS OF QUALITY CONTROL (QC) FOR EACH ASSAY WERE PERFORMING WITHIN THE LABORATORY'S ESTABLISHED RANGES FROM (B)(4) 2013. ROUTINE SYSTEM CHECKS, PERFORMED ON (B)(4) 2013, PASSED WITHIN INSTRUMENT SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SUPPRESSED IND (INDETERMINATE) FLAGGED TROPONIN I (ACCESS ACCUTNI) AND BETA HUMAN CHORIONIC GONADOTROPHIN (BHCG) RESULTS, FOR TWO SEPARATE PATIENTS, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM UTILIZED IN CONJUNCTION WITH THE ACCESS ACCUTNI AND ACCESS TOTAL SSHCG ASSAYS AND CALIBRATORS. SUBSEQUENT ANALYSIS OF THE PATIENTS¿ SAMPLES, ON AN ALTERNATE UNICEL DXC 600I ANALYZER PRODUCED NUMERICAL, REPORTABLE RESULTS. THE SUPPRESSED RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER INDICATED SEVERAL SAMPLE COUNTS OUTSIDE LIMITS ERRORS WERE IN THE EVENT LOG ON (B)(4) 2013. BECKMAN COULTER CUSTOMER TECHNICAL SERVICE (CTS) ADVISED THE CUSTOMER TO CHECK THE CAP AND FITTINGS ON THE SUBSTRATE BOTTLE, VERIFY THE SUBSTRATE PROBE FOR VISIBLE DAMAGE, AND PERFORM A COMPLETE SYSTEM CHECK. THE CUSTOMER NOTED THE BLACK FITTING ON THE TOP OF THE SUBSTRATE PROBE WAS VERY LOOSE AND TIGHTENED THE FITTING. SYSTEM CHECK WAS PERFORMED AND PASSED WITHIN SPECIFICATION. THE CUSTOMER NOTED BHCG AND TROPONIN I QUALITY CONTROL (QC) WAS LOW ON THE DAY OF THE EVENT AND PERFORMED ASSAY RECALIBRATION; QC HAS BEEN WITHIN THE LABORATORY'S RANGES. PATIENT SAMPLES WERE COLLECTED IN 12.75 MM BECTON DICKINSON (BD) LITHIUM HEPARIN TUBES AND WERE FULL COLLECTIONS WITH NO EVIDENCE OF FIBRIN. THE SAMPLES WERE CENTRIFUGED IN A STATSPIN CENTRIFUGE AT 7,200 RPM (ROTATIONS PER MINUTE) FOR FIVE MINUTES, AT ROOM TEMPERATURE. SAMPLES WERE LESS THAN ONE HOUR OLD PRIOR TO REANALYSIS. THE CUSTOMER STATED THE ISSUE WAS RESOLVED. THE INSTRUMENT WAS IN NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234932 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1