BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 3024287 · Received March 27, 2013

    Report

    Report Number
    2122870-2013-00323
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 1, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INITIALLY REPORTED OF OBTAINING ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS FOR SIX PATIENTS, BUT LATER PROVIDED RESULTS FOR TEN (10) PATIENTS. THIS REPORT DOCUMENTS THE EVENT CONCERNING THE FIVE (5) OF THE TEN (10) PATIENTS, AND THE EVENTS CONCERNING THE OTHER FIVE (5) PATIENTS ARE DOCUMENTED IN THE BELOW LISTED REPORTS: 2122870-2013-00385, 2122870-2013-00386, 2122870-2013-00387, 2122870-2013-00388, 2122870-2013-00389. THE INITIAL REPORT DOCUMENTED THAT THE CUSTOMER REANALYZED THE SAMPLES ON THE LABORATORY'S ALTERNATE ACCESS 2 ANALYZER, BUT THE PATIENT RESULTS PROVIDED BY THE CUSTOMER WERE FROM THE SAME INSTRUMENT FOR BOTH INITIAL AND REPEAT RESULTS. THIS REPORT DOCUMENTS THE CORRECTED DATE OF EVENT, (B)(6) 2013.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER THAT UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM GENERATED ERRONEOUSLY ELEVATED TROPONIN I (ACCUTNI) RESULTS FOR SIX PATIENTS. THE CUSTOMER REANALYZED THE SAMPLES ON THE LABORATORY'S ALTERNATE ACCESS 2 ANALYZER AND OBTAINED ACCUTNI RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT PROVIDE PERTINENT PATIENT RESULTS. THE CUSTOMER REPORTED THAT THE ERRONEOUS ACCUTNI RESULTS WERE RELEASED OUT OF THE LABORATORY BUT IT IS UNKNOWN IF THERE WAS ANY CHANGES TO PATIENT TREATMENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO VERIFY HARDWARE PERFORMANCE. THE FSE CLEANED A DRIED WASH BUFFER SPILL FROM THE WASH CAROUSEL AND THE REACTION VESSEL (RV) PATH. THE FSE REPLACED THE WASH PUMP SEAL, THE MIXER ROLLERS AND GEARS, THE PERI PUMP TUBING, AND THE SUBSTRATE PROBE. THE FSE PERFORMED SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK AFTER THE REPAIRS, AND OBTAINED RESULTS WITHIN THE INSTRUMENT SPECIFICATIONS. THE FSE CONFIRMED THAT THE CAUSE OF THE EVENT WAS HARDWARE MALFUNCTION, BUT WAS UNABLE TO DETERMINE THE SPECIFIC HARDWARE MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER PROVIDED THE PERTINENT TROPONIN (ACCUTNI) RESULTS OBTAINED FOR TEN (10) PATIENTS FROM THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. REPEAT TESTING WAS PERFORMED ON THE SAME INSTRUMENT AFTER SERVICE INTERVENTION AND PRODUCED LOWER RESULTS. THIS REPORT DOCUMENTS THE RESULTS OBTAINED FOR FIVE (5) OF THE TEN (10) PATIENTS. THE CUSTOMER REPORTED THAT THERE WAS NO CHANGE TO PATIENT TREATMENT FOR THESE FIVE (5) PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125534 UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1