BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2122870-2015-00224

    MDR report key: 4698194 · Received April 16, 2015

    Report

    Report Number
    2122870-2015-00224
    Event Type
    Malfunction
    Date Received
    April 16, 2015
    Date of Event
    March 20, 2015
    Report Date
    March 20, 2015
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ULTRASONICS GANTRY. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE. THE FSE PROACTIVELY PERFORMED PREVENTATIVE MAINTENANCE (PM) ON THE INSTRUMENT. THE FSE NOTED THE PM DID NOT RESOLVE THE ISSUE. THE FSE REPLACED THE ULTRASONICS GANTRY AND ASSOCIATED PRINTED CIRCUIT BOARD (PCB). REPLACEMENT OF THE ULTRASONICS GANTRY RESOLVED THE ISSUE. ALL VERIFICATION TESTING PASSED WITHIN PUBLISHED PERFORMANCE SPECIFICATIONS. IN CONCLUSION, A HARDWARE MALFUNCTION WAS THE CAUSE OF THE NON-REPRODUCIBLE, FALSELY ELEVATED ACCESS ACCUTNI+3 RESULTS. REPLACEMENT OF THE ULTRASONICS GANTRY (PART NUMBER 973098) RESOLVED THE ISSUE. ALL MDR'S ASSOCIATED WITH THIS REPORT: 2122870-2015-00222; 2122870-2015-00223. BECKMAN COULTER (BEC) INTERNAL PATIENT IDENTIFIER NUMBER IS (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A NON-REPRODUCIBLE, FALSELY ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR TEN (10) PATIENTS ON THE ACCESS 2 IMMUNOASSAY SYSTEM PORTION OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM (SERIAL NUMBER (B)(4)). THIS REPORT ADDRESSES THE NON-REPRODUCIBLE ELEVATED ACCESS ACCUTNI+3 RESULT OBTAINED ON (B)(6), 2015 FOR ONE (1) PATIENT. THE CUSTOMER REANALYZED THE PATIENT SAMPLES ON AN ALTERNATE ACCESS 2 IMMUNOASSAY SYSTEM SERIAL (SERIAL NUMBER (B)(4)) AND OBTAINED LOWER RESULTS, WITHIN THE CUSTOMER'S REFERENCE RANGE. THE NON-REPRODUCIBLE, FALSELY ELEVATED ACCESS ACCUTNI+3 RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. MDR#: 2122870-2015-00222 ADDRESSES THE RESULTS OBTAINED ON (B)(6) 2015 FOR SEVEN (7) PATIENTS. MDR#: 2122870-2015-00223 ADDRESSES THE RESULTS OBTAINED (B)(6) 2015 FOR TWO (2) PATIENTS. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. ALL SYSTEM PARAMETERS (INCLUDING QUALITY CONTROL, CALIBRATION AND SYSTEM CHECK) WERE WITHIN ASSAY/INSTRUMENT SPECIFICATIONS. THE PATIENT SAMPLES WERE COLLECTED IN SIX MILLILITER (6 ML) LITHIUM HEPARIN TUBES AND CENTRIFUGED AT 3600 REVOLUTIONS PER MINUTE (RPM) FOR TEN (10) MINUTES. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR