BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 3083755 · Received April 29, 2013

    Report

    Report Number
    2122870-2013-00412
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 30, 2013
    Report Date
    March 31, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED TOTAL BETA HUMAN CHORIONIC GONADOTROPHIN (TBHCG) RESULT, ABOVE THE NORMAL REFERENCE RANGE, FOR ONE PATIENT, INVOLVING THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH THE ACCESS TOTAL SSHCG ASSAY (LOT NO. 270183) AND CALIBRATOR (LOT NO. 218894). SUBSEQUENT ANALYSIS OF THE PATIENT SAMPLE, ON THE SAME INSTRUMENT, RECOVERED A LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULT WAS RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE HOSPITAL AS THE URINE ANALYSIS, FROM THE EMERGENCY ROOM (ER), PRODUCED A NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE FULL-DRAW SAMPLE WAS COLLECTED IN THE ER, IN A 13X75 MM SERUM SEPARATION TUBE (SST). THE CLOTTED SAMPLE WAS NORMAL IN APPEARANCE AND ANALYZED FROM THE PRIMARY TUBE. CENTRIFUGATION WAS PERFORMED AT 2,600 RPM (ROTATIONS PER MINUTE) FOR TEN MINUTES. THE CUSTOMER PERFORMS QUALITY CONTROL (QC) EVERY 24 HOURS; QC WAS WITHIN RANGE AT THE TIME OF THE EVENT. THE SAMPLE WAS ORIGINALLY ANALYZED FROM PIPETTOR #1 AND REANALYZED FROM PIPETTOR #2, LOADED THROUGH THE CLOSED TUBE ALIQUOTTER (CTA). SYSTEM CHECK WAS WITHIN SPECIFICATION AFTER THE DAY OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185440 UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DHA BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR