BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS ACCUTNI+3

    MDR report key: 4244039 · Received November 11, 2014

    Report

    Report Number
    2122870-2014-00749
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K121790
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION ACCUTNI+3 REAGENT WAS RETURNED TO BECKMAN COULTER (BEC) FOR INVESTIGATION. THERE WAS NO EVIDENCE OF AN INSTRUMENT MALFUNCTION AND BEC FIELD SERVICE WAS NOT DISPATCHED TO EVALUATE THE INSTRUMENT. THE CAUSE OF THE NONREPRODUCIBLE ACCUTNI+3 RESULTS COULD NOT BE DETERMINED FROM THE SUPPLIED INFORMATION. (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER 603579) GENERATED NONREPRODUCIBLE TROPONIN I (ACCUTNI+3) RESULTS FOR ONE PATIENT SAMPLE. THE PATIENT SAMPLE HAD BEEN INITIALLY TESTED ON (B)(6) 2014 AND GENERATED AN ELEVATED ACCUTNI+3 RESULT; THE CLINICIAN REQUESTED A RETEST. ON (B)(6) 2014, THE PATIENT SAMPLE (PREVIOUSLY ALIQUOTED) WAS RETESTED ON THE SAME ANALYZER, WHICH GENERATED FOUR NONREPRODUCIBLE ACCUTNI+3 RESULTS. THIS MDR REPORTS THE FOUR ACCUTNI+3 RESULTS GENERATED ON (B)(6) 2014. SYSTEM PARAMETERS SUCH AS QUALITY CONTROL (QC) RESULTS, CALIBRATION, AND SYSTEM CHECK WERE WITHIN SPECIFICATIONS. THERE WAS NO EVIDENCE OF A PREANALYTICAL SAMPLING HANDLING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726345 ACCESS ACCUTNI+3 IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 335791

    Patients

    Seq Age Sex Outcome Treatment
    1