BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM.

    MDR report key: 2230163 · Received September 1, 2011

    Report

    Report Number
    2122870-2011-03044
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 30, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECT TO THE PATIENT TREATMENT IS UNKNOWN AT THE TIME; HOWEVER SOME PATIENT WERE HELD FOR REPEAT TESTING AND OBSERVATION DUE TO THE ERRONEOUS RESULTS. TO: THE AFFECT TO THE PATIENT TREATMENT IS UNKNOWN AT THE TIME; HOWEVER THE PATIENT MAY HAVE BEEN HELD FOR REPEAT TESTING AND OBSERVATION DUE TO THE ERRONEOUS RESULT.

    Additional Manufacturer Narrative · 1

    THE ACCUTNI SAMPLE WAS COLLECTED IN A GREINER SERUM TUBE AND CENTRIFUGED FOR FIFTEEN (15) MINUTES AT 3000G AT 20°C. ACCUTNI QC HAS BEEN PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES. SPECIFIC QC DATA HAS NOT BEEN SUPPLIED TO DATE. PER THE CUSTOMER SUPPLIED DOCUMENTATION, ROUTINE SYSTEM CHECKS WERE PERFORMED ON (B)(6)-2011 AND (B)(6)-2011; BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. ON (B)(4) 2011 BEC FIELD SERVICE ENGINEER (FSE) PROVIDED PHONE SUPPORT. THE FSE INSTRUCTED THE CUSTOMER TO PERFORM A CARRYOVER TEST FOR THE CLOSE TUBE ACCESSION (CTA) AS THE CUSTOMER HAD RECEIVED AN OBSTRUCTION EVENT. THE FSE ANALYZED THE DATA AND THE CARRYOVER INDICATED SOME CARRYOVER WAS OCCURRING. THE CUSTOMER REPLACED THE CTA ALIQUOT PROBE AND PERFORMED ALL THE NECESSARY ALIGNMENTS. THE CUSTOMER REPEATED THE CTA CARRYOVER TEST; DATA ANALYSIS INDICATED MINIMAL IMPROVEMENT FROM THE PREVIOUS TEST. THE CUSTOMER PERFORMED A HIGH SENSITIVITY SYSTEM CHECK ON THE ACCESS 2 WHICH FAILED. THE CUSTOMER CHANGED THE ASPIRATE PROBES AND PERFORMED ANOTHER HIGH SENSITIVITY SYSTEM CHECK WHICH FAILED AGAIN. ON (B)(4) 2011, THE FSE WAS ON SITE AND REPLACED THE INCUBATOR BELT AND RV INCUBATOR BELT VESSEL HOLDERS AS THE BELT DOVE-TAILS SHOWED SOME DAMAGE. THE FSE PERFORMED ALL NECESSARY ALIGNMENTS. THE FSE THEN PERFORMED A ROUTINE SYSTEM CHECK, A HIGH SENSITIVITY SYSTEM CHECK AND A TEN REPLICATE ACCUTNI PRECISION TEST USING THE LEVEL 3 QC MATERIAL; ALL RESULTS WERE ACCEPTABLE. PER FSE, THE ROOT CAUSE FOR THE EVENT IS THE FAILURE OF THE INCUBATOR BELT.

    Additional Manufacturer Narrative · 1

    CHANGE FROM: THE SAMPLE WAS REPEATED ON THE SAME UNIT AND LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE. TO: THE SAMPLE WAS REPEATED ON THE SAME UNIT AND LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE WAS OBTAINED. CHANGE FROM: THE AFFECT TO THE PATIENT TREATMENT IS UNKNOWN AT THE TIME; HOWEVER SOME PATIENT WERE HELD FOR REPEAT TESTING AND OBSERVATION DUE TO THE ERRONEOUS RESULTS. TO: THE AFFECT TO THE PATIENT TREATMENT IS UNKNOWN AT THE TIME; HOWEVER THE PATIENT MAY HAVE BEEN HELD FOR REPEAT TESTING AND OBSERVATION DUE TO THE ERRONEOUS RESULT. (B)(4).

    Description of Event or Problem · 1

    THE SAMPLE WAS REPEATED ON THE SAME UNIT AND LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE WAS OBTAINED; HOWEVER, THE RESULT WAS STILL OUTSIDE OF THE ASSAY'S PRECISION CLAIM OF 20%. THE AFFECT TO THE PATIENT TREATMENT IS UNKNOWN AT THE TIME; HOWEVER THE PATIENT MAY HAVE BEEN HELD FOR REPEAT TESTING AND OBSERVATION DUE TO THE ERRONEOUS RESULT.

    Description of Event or Problem · 1

    THE AFFECT TO THE PATIENT TREATMENT IS UNKNOWN AT THE TIME; HOWEVER THE PATIENT MAY HAVE BEEN HELD FOR REPEAT TESTING ANDOBSERVATION DUE TO THE ERRONEOUS RESULT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING HIGHER THAN EXPECTED ACCUTNI RESULTS WITHIN THE RISK STRATIFICATION RANGE FOR ONE PATIENT GENERATED BY THE UNICEL DXC600I SYNCHRON ACCESS CLINICAL SYSTEM. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE CLINICIAN. THE SAMPLE WAS REPEATED ON THE SAME UNIT AND LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE WAS OBTAINED. THE AFFECT TO THE PATIENT TREATMENT IS UNKNOWN AT THE TIME; HOWEVER SOME PATIENT WERE HELD FOR REPEAT TESTING AND OBSERVATION DUE TO THE ERRONEOUS RESULTS. THIS MDR IS ASSOCIATED WITH THE MDRS LISTED BELOW. EACH MDR WILL CAPTURE AN INDIVIDUAL PATIENT EVENT. 2122870-2011-03043, 2122870-2011-03045, 2122870-2011-03047, 2122870-2011-03189 THRU TO 2122870-2011 03215.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM. DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE MMI BECKMAN COULTER INC. DXC 600 I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1