BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2152836 · Received July 7, 2011

    Report

    Report Number
    2122870-2011-02172
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 6, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLE WAS COLLECTED IN A 13X100MM GREINER LIHEP PLASMA TUBE AND CENTRIFUGED FOR 15 MINUTES AT 3500 G AT 15C. CUSTOMER NOTED THAT THE SAMPLE WAS A FULL DRAW AND NORMAL IN APPEARANCE. THE ORIGINAL RESULT WAS OBTAINED FROM THE PRIMARY COLLECTION TUBE. PER THE CUSTOMER, ACCUTNI QC HAS BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGES. SPECIFIC QC DATA HAS NOT BEEN SUPPLIED TO DATE. PER THE CUSTOMER SUPPLIED DOCUMENTATION, A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2011, AFTER THE CUSTOMER CHANGED THE ASPIRATE PROBES. THE SYSTEM CHECK FAILED DUE TO A WASHED %CV OF 38.91%. SYSTEM SPECIFICATION IS 0.00 - 12.00%. THE CUSTOMER REPEATED THE WASHED PORTION OF THE SYSTEM CHECK AFTER CLEANING THE ASPIRATE PROBES. THE SYSTEM CHECK FAILED AGAIN WITH A WASHED %CV OF 22.82%. BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. FSE REPLACED ALL THREE MIXER PULLEYS IN THE ANALYTICAL UNIT AND VERIFIED THE PERFORMANCE OF THE MIXER MOTOR, BELT AND SPRING RV TENSIONERS. NO ISSUES WERE NOTED. FSE PERFORMED DISPENSE PROBE VOLUME CHECKS AND NOTED BUBBLES COMING FROM DISPENSE PROBE #1. FSE CLEANED THE WASH PUMP, WASH VALVE AND ALL THREE DISPENSE PROBES. FSE THEN PERFORMED ANOTHER ROUTINE SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT OBTAINING AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE (1) PATIENT, GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LAB AND WAS QUESTIONED BY THE PHYSICIAN. SUBSEQUENT TESTING ON THE SAME INSTRUMENT PRODUCED A LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE. 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 DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE MMI BECKMAN COULTER INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1