BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS ACCUTNI

    MDR report key: 3831414 · Received May 25, 2014

    Report

    Report Number
    2122870-2014-00388
    Event Type
    Injury
    Date Received
    May 25, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 25, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K021814
    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 CUSTOMER DID NOT QUESTION INSTRUMENT PERFORMANCE; SERVICE WAS NOT DISPATCHED TO EVALUATE THE INSTRUMENT. THE CUSTOMER SENT THE PATIENT SAMPLE TO BECKMAN COULTER (BEC) FOR EVALUATION. PATIENT SAMPLE TESTING INDICATES THAT THERE IS A PATIENT-SOURCE HETEROPHILE INTERFERENT IN THE PATIENT'S SAMPLE CAUSING THE ELEVATED ACCUTNI RESULTS. BEC INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING REPRODUCIBLY ELEVATED TROPONIN I (ACCUTNI) RESULTS FOR MULTIPLE SAMPLES FROM ONE PATIENT ON (B)(6) 2013 AND ON (B)(6) 2014. RESULTS WERE GENERATED BY THE ACCESS 2 OF A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. AS A RESULT OF THE ELEVATED ACCUTNI RESULT OBTAINED ON (B)(6) 2014, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY WHERE A HEART CATHETERIZATION PROCEDURE WAS PERFORMED; THE FACILITY ALSO DREW A SAMPLE FROM THE PATIENT AND OBTAINED A NORMAL TROPONIN I RESULT WHEN TESTED ON AN ALTERNATE METHODOLOGY. ON ALL OTHER DATES, THERE WAS NO CHANGE OR IMPACT TO PATIENT TREATMENT. ACCUTNI WAS CALIBRATED WITH ACCUTNI CALIBRATOR LOT 335799 ON (B)(6) 2014; THE CALIBRATION CURVES MEET THE ASSAY'S SPECIFICATIONS. ROUTINE SYSTEM CHECKS WERE PERFORMED AND WERE WITHIN INSTRUMENT SPECIFICATIONS MULTIPLE TIMES DURING THE TIMEFRAME OF THIS EVENT. THE CUSTOMER PROVIDED QUALITY CONTROL (QC) DATA FOR REVIEW AND RESULTS WERE WITHIN THE LABORATORY'S ESTABLISHED RANGES FOR THE DATE OF THIS EVENT. THE PATIENT'S SAMPLES WERE COLLECTED IN HEPARINIZED PLASMA TUBES AND CENTRIFUGED FOR 5 TO 9 MINUTES AT ROOM TEMPERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309770 ACCESS ACCUTNI IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 336053

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other