BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1850460 · Received October 1, 2010

    Report

    Report Number
    2122870-2010-00585
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE CUSTOMER, PATIENT #1 IS A (B)(6) YEAR OLD MALE, PATIENT #2 IS AN (B)(6) YEAR OLD FEMALE, AND PATIENT #3 IS A (B)(6) YEAR OLD FEMALE. THE CUSTOMER COLLECTS FRT4 SAMPLES IN BOTH LIHEP PLASMA TUBES AND SERUM TUBES AND CENTRIFUGED THEM FOR 15 MINUTES AT 3000 RPM. THE CUSTOMER STATED TO THE CUSTOMER TECHNICAL SUPPORT (CTS) THAT ALL ORIGINAL AND REPEAT RESULTS WERE ANALYZED THROUGH THE INSTRUMENT'S CLOSED TUBE ALIQUOTTER (CTA). PER THE CUSTOMER SUPPLIED QC CHARTS, BOTH LEVELS OF FRT4 QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2010 FOR THIS EVENT. THE FSE PERFORMED A CTA CARRYOVER TEST WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE FSE PERFORMED A ROUTINE SYSTEM CHECK WHICH FAILED. THE FSE CHECKED THE ASPIRATE PROBES AND REPLACED THE PERI-PUMP TUBING, AND ADJUSTED THE DRIFT CONTROL FACTOR FOR THE LUMINOMETER. PERFORMED A SYSTEM CHECK AND PRECISION TEST WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY HIGH FRT4 RESULTS ABOVE THE NORMAL REFERENCE RANGE FOR THREE PATIENTS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. SUBSEQUENT TESTING PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE FOR ALL THREE PATIENTS. ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. HOWEVER, THESE RESULTS WERE AMENDED BY THE SUBSEQUENT RESULTS. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1