BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® ACCUTNI+3 REAGENT

    MDR report key: 3408810 · Received October 14, 2013

    Report

    Report Number
    2122870-2013-00831
    Event Type
    Injury
    Date Received
    October 14, 2013
    Date of Event
    September 17, 2013
    Report Date
    September 18, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K121214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE ON (B)(4) 2013. THE FSE PERFORMED MINOR PREVENTATIVE MAINTENANCE ON THE INSTRUMENT BUT DID NOT NOTE OF ANY INSTRUMENT ISSUES. THE FSE VERIFIED THE INSTRUMENT AS PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. THE CAUSE OF THE DISCREPANT TROPONIN I PATIENT RESULTS CANNOT BE DETERMINED WITH THE SUPPLIED INFORMATION; THE FSE EVALUATED THE INSTRUMENT AND THERE IS NO EVIDENCE TO REASONABLY SUGGEST AN INSTRUMENT MALFUNCTION. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2122870-2013-00831, 2122870-2013-00832.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NOTICING AN INCREASE IN THE NUMBER OF ELEVATED ACCESS ACCUTNI+3 (TROPONIN I) RESULTS INVOLVING THE ACCESS 2 IMMUNOASSAY ANALYZER. SUBSEQUENT REPEAT OF THE PATIENT SAMPLES ON AN ALTERNATE NON-BECKMAN COULTER POINT-OF-CARE DEVICE PRODUCED NEGATIVE RESULTS. THE CUSTOMER DID NOT REPEAT ANY SAMPLES ON THE ACCESS 2 INSTRUMENT AND DID NOT PROVIDE ANY SAMPLES TO BECKMAN COULTER FOR FURTHER TESTING. THIS REPORT REFERENCES ONE OF THE TWO PATIENTS INVOLVED IN THE EVENT WHICH OCCURRED ON (B)(6) 2013; PLEASE REFER TO MEDWATCH REPORT #2122870-2013-00832 FOR A REPORT OF THE OTHER PATIENT. THE ELEVATED ACCUTNI+3 RESULT FOR THIS PATIENT WAS REPORTED OUT OF THE LABORATORY AND THE PATIENT WAS ADMITTED TO THE HOSPITAL AS A RESULT OF THE POSITIVE ACCUTNI+3 RESULT. THE SAMPLE WAS COLLECTED IN LITHIUM HEPARIN PLASMA TUBES AND CENTRIFUGED AT 3000 RPM FOR TEN MINUTES. ALL THREE LEVELS OF QUALITY CONTROL (QC) RESULTS WERE WITHIN THE LABORATORY'S ESTABLISHED RANGES ON THE DAY OF THE EVENT. THE CUSTOMER HAD A PASSING ACCUTNI+3 CALIBRATION ON (B)(6) 2013 USING THE ACCESS ACCUTNI+3 REAGENT LOT 230695 AND ACCESS ACCUTNI+3 CALIBRATOR LOT 228308. THE CUSTOMER ALSO OBTAINED A PASSING SYSTEM CHECK ON (B)(6) 2013. THE ACCESS ACCUTNI+3 REAGENT WAS USED IN CONJUNCTION WITH THE ACCESS 2 IMMUNOASSAY ANALYZER SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525172 ACCESS® ACCUTNI+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 230695

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization