BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS ACCUTNI+3 REAGENT

    MDR report key: 4100319 · Received September 18, 2014

    Report

    Report Number
    2122870-2014-00627
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K121214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING ROUTINE TROUBLESHOOTING WITH HOTLINE, IT WAS DETERMINED THAT SERVICE WAS NECESSARY TO ADDRESS A POTENTIAL ASPIRATE PROBE LOCKING ISSUE. THE FSE DETERMINED THE ASPIRATE PROBE WAS LOCKING PROPERLY IN PLACE, BUT DISCOVERED ASPIRATE PROBE #2 TUBING WAS ROUTED INCORRECTLY AND THE LUMINOMETER WAS NOT PERFORMING WITHIN SPECIFICATION. THE FSE REPLACED THE TUBING AND LUMINOMETER AND VERIFIED SYSTEM PERFORMANCE WITH SYSTEM CHECK, HS (HIGH SENSITIVITY) SYSTEM CHECK, AND CTAI CARRYOVER. CALIBRATION AND QC WERE TO BE COMPLETED BY THE CUSTOMER. ALTHOUGH USE ERROR MAY HAVE CONTRIBUTED TO THE EVENT, A SPECIFIC CAUSE OF THE NON-REPRODUCIBLE TROPONIN RESULT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THERE IS NO INDICATION THAT ACCESS ACCUTNI+3 REAGENT WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING A NON-REPRODUCIBLE TROPONIN (ACCUTNI+3) RESULT ON THE ACCESS 2 IMMUNOASSAY ANALYZER PORTION (SERIAL NUMBER: (B)(4)) OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER STATED THAT HIGH VALUES WERE REPEATED ON THE SAME ANALYZER AS LAB PRACTICE. UPON REPEAT, THE RESULT WAS LOWER. THE SAMPLE WAS ALIQUOTED INTO A CUP AND REPEATED ON THE SAME ANALYZER AND ON THE ALTERNATE STANDALONE ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER: (B)(4)), AND BOTH ANALYZERS OBTAINED NEGATIVE RESULTS. THE INITIAL HIGH RESULT WAS REPORTED FROM THE LABORATORY, BUT THE CUSTOMER CORRECTED THE RESULT TO 0.00NG/ML. PLEASE REFER TO THE ATTACHED PATIENT DATA TABLE. THE CUSTOMER STATED THERE WAS NO CHANGE OR IMPACT TO PATIENT CARE OR TREATMENT. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580030 ACCESS ACCUTNI+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 424514

    Patients

    Seq Age Sex Outcome Treatment
    1