BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2211589 · Received August 5, 2011

    Report

    Report Number
    2050012-2011-03885
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JLB
    PMA / PMN Number
    K060256
    Removal / Correction Number
    Z-0914-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) SERVICED THE UNIT AT THE FACILITY ON (B)(4) 2008 AND DISCOVERED THE TRANSDUCER WOULD NOT SET TO HIGH VOLTAGE. THE FSE REPLACED THE TRANSDUCER AND THE PERISTALTIC PUMP TUBING DUE TO HIGH FAILURE RATE. THE FSE PERFORMED ALIGNMENTS, COMPLETED SYSTEMS CHECK, COMPLETED LUMWASH SON INC. PROCEDURE, PERFORMED PRECISION TESTS AND MANUALLY COMPLETED ACCURACY AND CARRYOVER TEST. THE CUSTOMER PERFORMED QUALITY CONTROL (QC). THE FSE LATER REPLACED THE PERISTALTIC PUMP ON THE UNIT. ALL TEST RESULTS CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS. BECKMAN COULTER SYSTEM TECHNICAL SUPPORT (STS) FURTHER NOTED THE TRANSDUCER VOLTAGE WAS UNRELATED TO THE ELEVATED CREATINE KINASE-MB (CK-MB) RESULTS, BECAUSE A DEFECTIVE TRANSDUCER WOULD LIKELY CAUSE UNDER-MIXING AND DOSE UNDER-RECOVERY FOR A ONE-STEP ASSAY, SUCH AS CK-MB. STS STATED THE PERISTALTIC PUMP TUBING LEAKAGE WAS THE LIKELY CAUSE OF THE ELEVATED RESULTS. THIS ISSUE WOULD EXHIBIT IMPROPER MIXING IN THE REACTION VESSELS (RVS), INCOMPLETE ASPIRATION AND POSSIBLE "TOUCH-OFF" CARRYOVER, CAUSING OVER-RECOVERY AND ERRATIC, HIGH CK-MB RESULTS. SAMPLES WERE COLLECTED IN PLASTIC BD LITHIUM HEPARIN TUBES WITH GEL. SAMPLE CENTRIFUGATION WAS PERFORMED AT 3,500 RPM (ROTATIONS PER MINUTE) FOR 10 MINUTES. ALL TESTS WERE SAMPLED FROM THE PRIMARY TUBE. CK-MB QUALITY CONTROL WAS WITHIN SPECIFICATIONS PRIOR TO THE EVENT. THE CUSTOMER NOTED THERE WERE SOME QUALITY CONTROL ERRATIC RECOVERIES AT THE TIME OF THE EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM JANUARY 01, 2008 THROUGH OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED CREATINE KINASE-MB (CK-MB) RESULTS, ABOVE THE NORMAL REFERENCE RANGE, FOR ONE PATIENT INVOLVING UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND ASSESSED THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM JLB BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM