BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 4765538 · Received May 12, 2015

    Report

    Report Number
    2122870-2015-00276
    Event Type
    Malfunction
    Date Received
    May 12, 2015
    Date of Event
    April 18, 2015
    Report Date
    April 18, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ON-SITE BIOMEDICAL ENGINEER EVALUATED THE INSTRUMENT. THE BIOMEDICAL ENGINEER FLUSHED THE VACUUM PUMP, CLEANED THE PINCH ROLLERS AND INSTALLED A NEW PINCH ROLLER SPINDLE. AFTER THE REPAIRS WERE COMPLETED, ALL VERIFICATION TESTING PASSED WITHIN PUBLISHED PERFORMANCE SPECIFICATIONS. IN CONCLUSION, THE CAUSE OF THE NON-REPRODUCIBLE (ACCESS ACCUTNI+3) AND TRIAGE BNP RESULTS IS DUE TO A HARDWARE MALFUNCTION, ALTHOUGH NO ONE PART CAN BE IMPLICATED AS THE SOLE CONTRIBUTOR IN THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING A NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR ONE (1) PATIENT AND A NON-REPRODUCIBLE BRAIN NATRIURETIC PEPTIDE (TRIAGE BNP) RESULT FOR A SECOND PATIENT INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM PORTION OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM SERIAL NUMBER (B)(4). THE SAMPLE FOR THE FIRST PATIENT (DESIGNATED AS PATIENT 1) WAS REPEATED ON AN ALTERNATE ACCESS 2 IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4), AND A LOWER RESULT, WITHIN THE CUSTOMER'S NORMAL REFERENCE RANGE, WAS GENERATED. THIS SAMPLE WAS THEN REANALYZED ON THE ORIGINAL ACCESS 2 IMMUNOASSAY SYSTEM PORTION OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM AND A HIGHER RESULT, OUTSIDE OF THE CUSTOMER'S NORMAL REFERENCE RANGE, WAS GENERATED. THE SAMPLE FROM THE SECOND PATIENT (DESIGNATED AS PATIENT 2) WAS REANALYZED TWICE ON THE ALTERNATE ACCESS 2 IMMUNOASSAY SYSTEM AND LOWER RESULTS, WITHIN THE ASSAY'S NORMAL REFERENCE RANGE, WERE GENERATED BOTH TIMES. ALTHOUGH THE ELEVATED RESULTS WERE RELEASED FROM THE LABORATORY, THERE WAS NO CHANGE OR IMPACT TO PATIENT CARE OR TREATMENT WHICH OCCURRED IN ASSOCIATION WITH THE NON-REPRODUCIBLE ACCESS ACCUTNI+3 OR TRIAGE BNP RESULTS. THE CUSTOMER'S ON-SITE BIOMEDICAL ENGINEER WAS CALLED TO ASSESS INSTRUMENT PERFORMANCE. QUALITY CONTROL (QC) AND CALIBRATION PARAMETERS WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT. SYSTEM CHECKS PERFORMED AFTER THE EVENT FAILED TO MEET INSTRUMENT SPECIFICATIONS. PATIENT ONE'S SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN (PLASMA SEPARATING TUBE). PATIENT TWO'S SAMPLE WAS COLLECTED IN AN EDTA (ETHYLENEDIAMINETETRAACETIC ACID) TUBE. BOTH SAMPLES WERE CENTRIFUGED FOR SIX (6) MINUTES AT 5000 RPM (REVOLUTIONS PER MINUTE). NO SAMPLE INTEGRITY ISSUES FOR EITHER SAMPLE WERE NOTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309409 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1