BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2585856 · Received May 23, 2012

    Report

    Report Number
    2122870-2012-01363
    Event Type
    Injury
    Date Received
    May 23, 2012
    Date of Event
    April 30, 2012
    Report Date
    May 2, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2012, FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) PERFORMED SOME HARDWARE COMPONENT REPLACEMENTS AFTER A HIGH SENSITIVITY SYSTEM CHECK PERFORMED BY THE FSE GENERATED FAILING RESULTS. THE HARDWARE REPLACEMENTS COMPLETED BY THE FSE, WHICH INCLUDED THE PRECISION PUMP, PRECISION PUMP MANIFOLD, AND INSTRUMENT PROBES AND TUBING, ALLOWED THE HIGH SENSITIVITY SYSTEM CHECK TO BE REPEATED WITH PASSING RESULTS WITHIN INSTRUMENT SPECIFICATIONS. UPON THE COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. ALTHOUGH THE FSE DID NOT PRODUCE EVIDENCE TO IMPLICATE A SPECIFIC HARDWARE COMPONENT AS THE CAUSE OF THE EVENT, THE HARDWARE REPLACEMENTS DID RESOLVE ISSUES OBSERVED DURING THE SERVICE VISIT. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2012-01362, 2122870-2012-01363, 2122870-2012-01401, 2122870-2012-01374.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ELEVATED CARDIAC TROPONIN (ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) THRESHOLD OF THE ASSAY, WERE GENERATED ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR EIGHT PATIENTS ACROSS MULTIPLE DAYS. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED PATIENT DATA INDICATES THAT ONLY SIX PATIENT SAMPLES GENERATED ERRONEOUS, NONREPRODUCIBLE ACCUTNI RESULTS. TWO ADDITIONAL PATIENT RESULTS WERE PROVIDED HOWEVER THE ACCUTNI RESULTS FOR THESE PATIENTS WERE BOTH REPRODUCIBLE WITHIN THE SAME CLINICAL CATEGORY AND WITHIN THE ASSAYS PRECISION LIMITS. THE CUSTOMER DID NOT INDICATE ANY DISCREPANT RESULTS WERE OBTAINED AT A LATER DATE FOR EITHER OF THESE TWO PATIENTS, AND HENCE THESE PATIENTS WERE NOT REGARDED AS ERRONEOUS AND NOT INCLUDED IN THIS REPORT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED PATIENT DATA INDICATES THAT FOUR OF THE PATIENTS INVOLVED IN THIS EVENT GENERATED ERRONEOUS ELEVATED ACCUTNI RESULTS ON (B)(6) 2012. REPEAT TESTING OF TWO OF THE PATIENT'S SAMPLES PRODUCED LOWER RESULTS WITHIN THE NORMAL RANGE OF THE ASSAY. REPEAT TESTING OF THE TWO OTHER PATIENT SAMPLES PRODUCED LOWER RESULTS WITHIN THE RISK STRATIFICATION RANGE OF THE ASSAY. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. IN TWO CASES, PATIENT TREATMENT WAS AFFECTED, WITH ONE PATIENT UNDERGOING AN UNDISCLOSED PROCEDURE IN THE CATHETERIZATION LABORATORY AND A SECOND PATIENT HAVING A THERAPEUTIC PATCH ADMINISTERED. THE CUSTOMER REPORTED THAT AFTER REPEAT TESTING WAS PERFORMED AND THE PATIENT REPORT WAS CORRECTED THE DOCTOR DISCONTINUED THE PATCH FOR THE PATIENT TO WHICH IT WAS ADMINISTERED. IN THE OTHER TWO CASES, THERE WAS NO MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER HAS NOT BEEN ABLE TO INDICATE WHICH PATIENTS RECEIVED CHANGES IN TREATMENT. FOR THE PURPOSES OF REPORTING, THIS REPORT WILL BE ALLOCATED TO ONE PATIENT WHOSE TREATMENT WAS IMPACTED BY THIS EVENT. ALTHOUGH ADDITIONAL ASSAY RESULTS WERE PROVIDED FOR THESE PATIENTS, NO OTHER PATIENT ASSAY RESULTS ARE IN QUESTION AS PART OF THIS EVENT. THE SAMPLES WERE FULL SAMPLES COLLECTED IN LITHIUM HEPARIN TUBES. THE SAMPLES APPEARED NORMAL IN APPEARANCE WITH NO VISIBLE ABNORMALITIES. THE SAMPLES WERE CENTRIFUGED PRIOR TO TESTING. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT ASSAY PERFORMANCE DATA INDICATED THAT QUALITY CONTROL RESULTS WERE PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED LIMITS AT THE TIME OF THE EVENT. SYSTEM CHECKS PERFORMED ON THE (B)(6) 2012, PASSED WITHIN INSTRUMENT SPECIFICATIONS. ACCUTNI CALIBRATION CURVES IN USE AT THE TIME OF THE EVENT WERE PASSING WITHOUT ANY ISSUES. THE REAGENT LOT NUMBER AND CALIBRATOR LOT NUMBER ASSOCIATED WITH THIS EVENT WAS 122056 AND 116461 RESPECTIVELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention