BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS ACCUTNI+3 REAGENT

    MDR report key: 6070293 · Received November 1, 2016

    Report

    Report Number
    2122870-2016-00514
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    September 22, 2016
    Report Date
    October 9, 2016
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590209322
    PMA / PMN Number
    K121214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS: AGE, DATE OF BIRTH, SEX OR WEIGHT. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED. THE CUSTOMER RELATED THAT A SAMPLE INTERFERENCE PHENOMENA IS SUSPECTED; HOWEVER THIS COULD NOT BE CORROBORATED BY BEC AS NO SAMPLE HAS BEEN MADE AVAILABLE FOR INTERNAL TESTING. THERE IS NO INDICATION THAT THE ACCESS ACCUTNI+3 REAGENT WAS RETURNED FOR EVALUATION. IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE SUPPLIED INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4) AND THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4) FOR ONE (1) PATIENT SAMPLE. THE ORIGINAL ELEVATED RESULT WAS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4) AND WAS REPEATED TWICE ON THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4) AND LOWER, BUT STILL ELEVATED RESULTS, ABOVE THE ASSAY'S NORMAL REFERENCE RANGE, WERE OBTAINED. THE SAMPLE WAS ALSO ANALYZED ON BOTH AN I-STAT INSTRUMENT AND AN ABBOTT ARCHITECT ANALYZER AND LOWER/NORMAL RESULTS WERE OBTAINED ON BOTH METHODOLOGIES. THERE WAS NO REPORTED CHANGE OR IMPACT TO PATIENT CARE OR TREATMENT WHICH OCCURRED IN ASSOCIATION WITH THE REPRODUCIBLE ELEVATED ACCESS ACCUTNI+3 RESULTS. QUALITY CONTROL (QC), CALIBRATION, AND SYSTEM CHECK WERE ALL PERFORMING WITHIN THE ASSAY'S AND INSTRUMENT'S SPECIFICATIONS AT THE TIME OF THE EVENT. THE PATIENT'S SAMPLE WAS COLLECTED IN A HEPARIN PLASMA TUBE AND WAS CENTRIFUGED FOR TEN (10) MINUTES AT 3000 G. NO ISSUES WITH SAMPLE INTEGRITY WERE NOTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721377 ACCESS ACCUTNI+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 624362 15099590209322

    Patients

    Seq Age Sex Outcome Treatment
    1