BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2122870-2016-00024

    MDR report key: 5356767 · Received January 11, 2016

    Report

    Report Number
    2122870-2016-00024
    Event Type
    Malfunction
    Date Received
    January 11, 2016
    Date of Event
    December 23, 2015
    Report Date
    December 23, 2015
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, AND WEIGHT WERE NOT SUPPLIED BY THE CUSTOMER. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE. THE FSE OBSERVED BUBBLES IN THE WASH PUMP ASSEMBLY. THE FSE REPLACED THE ROTOR, STATOR, AND SEAL COMPONENTS IN THE WASH VALVE TO RESOLVE THE ISSUE. AFTER THE REPAIRS WERE COMPLETED ALL VERIFICATION TESTING PASSED WITHIN PUBLISHED PERFORMANCE SPECIFICATIONS. IN CONCLUSION, THE CAUSE OF THE NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3) RESULT IS DUE TO A HARDWARE MALFUNCTION, ALTHOUGH NO ONE PART CAN BE IMPLICATED AS THE SOLE CONTRIBUTOR IN THIS EVENT. BECKMAN COULTER (BEC) INTERNAL PATIENT IDENTIFIER FOR THIS REPORT IS (B)(6). ALL MDRS ASSOCIATED WITH THIS EVENT: 2122870-2016-00022, 2122870-2016-00023, 2122870-2016-00024.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE ACCESS ACCUTNI+3 RESULTS IN ASSOCIATION WITH THE ACCESS 2 IMMUNOASSAY SYSTEM PORTION OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM SERIAL NUMBER (B)(4) FOR FOUR (4) PATIENTS. THE SAMPLE FROM THE FOURTH PATIENT (DESIGNATED AS PATIENT FOUR (4)) WAS RETESTED USING THE ALTERNATE ACCESS 2 IMMUNOASSAY SYSTEM PORTION OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM SERIAL NUMBER (B)(4) AND A LOWER RESULT, WITHIN THE ASSAY'S NORMAL REFERENCE RANGE, WAS OBTAINED. THE CUSTOMER STATED THE NON-REPRODUCIBLE ACCESS ACCUTNI+3 RESULT ASSOCIATED WITH PATIENT FOUR (4) WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO REPORTED CHANGE OR IMPACT TO PATIENT CARE OR TREATMENT IN ASSOCIATION WITH THE NON-REPRODUCIBLE ACCESS ACCUTNI+3 RESULTS. MDRS 2122078-2016-00022 AND 2122078-2016-00023 WILL ADDRESS THE NON-REPRODUCIBLE ACCESS ACCUTNI+3 RESULTS ASSOCIATED WITH THE THREE (3) ADDITIONAL PATIENTS THE CUSTOMER DID NOT SUPPLY ANY QUALITY CONTROL (QC) INFORMATION REGARDING THIS EVENT. THE SAMPLE WAS PLASMA, COLLECTED IN LITHIUM HEPARIN TUBES. THE SAMPLE WAS CENTRIFUGED FOR TEN (10) MINUTES AT 3400 REVOLUTIONS PER MINUTE (RPM) AT ROOM TEMPERATURE. NO SAMPLE INTEGRITY ISSUES WERE REPORTED BY THE CUSTOMER. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE.

    Patients

    Seq Age Sex Outcome Treatment
    1