BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 4243994 · Received November 11, 2014

    Report

    Report Number
    2122870-2014-00756
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 15, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE REPLACED THE TRANSDUCER AND X/Y SERVICE LOOP TO RESOLVE THE ISSUE. THE FSE VERIFIED THE INSTRUMENT TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES AND THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING FALSE HIGH TROPONIN I (ACCUTNI+3) RESULTS FOR TWO PATIENTS ON THE ACCESS 2 IMMUNOASSAY SYSTEM. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND GENERATED LOWER RESULTS. PLEASE REFER TO THE PATIENT DATA TABLE ATTACHED. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY, BUT THERE WAS NO REPORT OF CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE SAMPLES WERE COLLECTED IN LITHIUM HEPARIN (GREEN TOP) AND PLAIN (RED TOP) 500 MICROLITER TUBES. THE SAMPLES WERE CENTRIFUGED AT THREE THOUSANDS (3000) ROTATION PER MINUTES (RPM) FOR FIVE (5) MINUTES AND AT TWENTY (20) DEGREE CELSIUS. THERE WAS NO EVIDENCE OF PRE-ANALYTICAL SAMPLE HANDLING ISSUE. THE CUSTOMER STATED THAT THE ACCUTNI+3 QUALITY CONTROL (QC) WAS WITHIN RANGE AT THE TIME OF THE EVENT. HOWEVER, THE QC FROM DIFFERENT ASSAYS SUCH AS VITAMIN B12 (VITB12), FOLATE (FOLW) AND CREATINE KINASE-MB (CK-MB) WERE OUT OF RANGE. 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
    726233 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1