BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 3034064 · Received April 3, 2013

    Report

    Report Number
    2122870-2013-00340
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Removal / Correction Number
    Z-1736-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) ASSESSED THE INSTRUMENT AND NO ISSUES WERE NOTED. THE SAMPLE PROBE CARRYOVER TEST PASSED AND HIGH SENSITIVITY SYSTEM CHECK PASSED WITHIN SPECIFICATION. QUALITY CONTROL (QC) WAS WITHIN THE LABORATORY'S ESTABLISHED LIMITS. THE INSTRUMENT PERFORMED WITHIN PUBLISHED PERFORMANCE SPECIFICATIONS. A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN. THE PATIENT'S SAMPLE WAS COLLECTED IN A 13X100 MM GREEN TOP TUBE AND CENTRIFUGED AT 3,000 RPM (ROTATIONS PER MINUTE) FOR SEVEN MINUTES. THE SAMPLE WAS ANALYZED ON THE DAY OF COLLECTION AND REFRIGERATED AFTER THE ANALYSIS. SAMPLE QUALITY APPEARED NORMAL. THE LABORATORY PERFORMS QUALITY CONTROL (QC) EVERY EIGHT HOURS. QC WAS WITHIN RANGE AT THE TIME OF THE EVENT. THE CUSTOMER REANALYZED RECENT AND ANY NEW POSITIVE RESULTS FOR ACCURACY VERIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED BETA HUMAN CHORIONIC GONADOTROPHIN (HCG) RESULT, FOR ONE PATIENT, INVOLVING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM UTILIZED WITH THE ACCESS TOTAL SSHCG ASSAY AND CALIBRATORS. SUBSEQUENT ANALYSES OF THE PATIENT'S SAMPLE, ON AN ALTERNATE UNICEL DXI 800 SYSTEM, RECOVERED LOWER RESULTS, WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULT WAS RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN AS IT DID NOT MATCH THE PATIENT'S CLINICAL PRESENTATION. AN AMENDED REPORT WAS ISSUED. THE CUSTOMER COULD NOT CONFIRM IF THERE WAS ANY CHANGE TO PATIENT CARE. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE INITIAL SAMPLE WAS TESTED THROUGH THE AUTOMATION LINE, AND THE REPEAT SAMPLE WAS PROGRAMMED MANUALLY AND TESTED THROUGH THE SPECIMEN PROCESSING UNIT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136536 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DHA BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR