BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS ACCUTNI+3 REAGENT

    MDR report key: 4704148 · Received April 17, 2015

    Report

    Report Number
    2122870-2015-00232
    Event Type
    Injury
    Date Received
    April 17, 2015
    Date of Event
    March 23, 2015
    Report Date
    March 24, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K121790
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MONTH AND DAY OF BIRTH WERE NOT PROVIDED.THE WEIGHT OF THE PATIENT WAS NOT PROVIDED.A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED. ALL SYSTEM PARAMETERS (INCLUDING QUALITY CONTROL, SYSTEM CHECK, CALIBRATION AND PRECISION RUN) WERE WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS. THE ACCESS ACCUTNI+3 REAGENT WAS NOT RETURNED FOR EVALUATION.IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A NON-REPRODUCIBLE, ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULT ON THEIR UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER 901013) FOR ONE (1) PATIENT. THE INITIAL, ELEVATEDRESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT HAD THREE (3) SUBSEQUENT BLOOD DRAWS. THE ACCESS ACCUTNI+3 RESULTS FOR THE SUBSEQUENT BLOOD DRAWS WERE ALL LOWER, WITHIN THE CUSTOMER'S REFERENCE RANGE. THE CUSTOMER REPEATED THE INITIAL SAMPLE THAT GAVE THE ELEVATED ACCESS ACCUTNI+3 RESULT ON THE SAME UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM AND OBTAINED A LOWER RESULT, WITHIN THE CUSTOMER'S ESTABLISHED NORMAL REFERENCE RANGE. THERE WAS A REPORT OF CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT AS THE PATIENT WAS ADMITTED TO THE HOSPITAL IN ASSOCIATION WITHTHE ELEVATED ACCESS ACCUTNI+3 RESULT OBTAINED. ALL SYSTEM PARAMETERS (INCLUDING QUALITY CONTROL (QC), CALIBRATION AND SYSTEM CHECK) WERE PERFORMING WITHIN ASSAY/INSTRUMENT SPECIFICATIONS. THE PATIENT SAMPLES WERE COLLECTED IN LITHIUM HEPARIN PLASMA TUBES AND CENTRIFUGED AT 5000 REVOLUTIONS PER MINUTE (RPM) FOR FIVE (5) MINUTES. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257931 ACCESS ACCUTNI+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 432479

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization