BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3280724 · Received August 11, 2013

    Report

    Report Number
    2122870-2013-00697
    Event Type
    Malfunction
    Date Received
    August 11, 2013
    Date of Event
    July 23, 2013
    Report Date
    July 23, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JLW
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPORTED THE PIPETTE ALIGNMENTS WERE NOT WITHIN SPECIFICATION WHICH CAUSED THE PIPETTE TIP TO CONTACT THE INTERIOR WALL OF REACTION VESSELS (RVS). THE FSE REPLACED THE INSTALLED PIPETTE TIP AND ADJUSTED PIPETTE ALIGNMENTS. THE FSE PERFORMED VERIFICATION TESTING AFTER REPAIRS WERE COMPLETE AND ACCEPTABLE RESULTS WERE OBTAINED. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT WAS THE PIPETTE ALIGNMENT. BECKMAN COULTER CONTINUES TO TRACK AND TREND ANY EVENT RELATED TO THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS PARATHYROID HORMONE (PTH) AND THYROID-STIMULATING HORMONE (TSH) RESULTS, FOR TEN PATIENTS, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER INDICATED ONE PATIENT OBTAINED AN INITIAL PTH RESULT OF 0.00 PG/ML. THE SAMPLE WAS THEN ANALYZED ON AN ALTERNATE ACCESS INSTRUMENT AND GENERATED A HIGHER RESULT OF 12.6 PG/ML. THE CUSTOMER STATED ALL TEN PATIENTS¿ SAMPLES GENERATED INITIAL PTH AND TSH RESULTS OF ZERO (0.00 PG/ML) AND WERE ALL SUBSEQUENTLY ANALYZED ON THE ALTERNATE ACCESS INSTRUMENT (ACTUAL VALUES WERE NOT SUPPLIED). THE CUSTOMER ALSO REPORTED PHASE LOCK LOOPS ERRORS AT THE TIME OF THE EVENT. NONE OF THE PATIENTS¿ ORIGINAL RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOTE THAT ONE OF THE PATIENTS WAS IN THE OPERATING ROOM (OR) PRIOR TO THIS EVENT. QUALITY CONTROL (QC) PASSED PRIOR TO THE EVENT AND PRODUCED QNS (QUANTITY NOT SUFFICIENT) MESSAGES AFTER THE ERRONEOUS RESULTS WERE OBTAINED. THE SERUM PATIENTS¿ SAMPLES WERE ANALYZED THROUGH CLOSED TUBE ALIQUOTTER (CTA) IN 16/100 TUBES AND CENTRIFUGED AT 3,500 RPM (ROTATIONS PER MINUTE) FOR THREE MINUTES. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385131 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JLW BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1