BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® ACCUTNI

    MDR report key: 3801260 · Received May 8, 2014

    Report

    Report Number
    2122870-2014-00344
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE ACCESS® ACCUTNI DEVICE WAS RETURNED FOR EVALUATION. SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. IN CONCLUSION, A DEFINITIVE CAUSE OF THE INCIDENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED FALSE POSITIVE TROPONIN I (ACCESS® ACCUTNI) RESULTS, FOR TWO PATIENTS, INVOLVING THE ACCESS® ACCUTNI ASSAY USED IN CONJUNCTION WITH THE ACCESS® 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. SUBSEQUENT TESTING OF THE PATIENTS' SAMPLES, ON AN ALTERNATE ACCESS® 2 SYSTEM, GENERATED LOWER RESULTS, WITHIN THE NORMAL REFERENCE RANGE. THE PATIENTS' SAMPLES WERE CENTRIFUGED AT 4,200G (RELATIVE CENTRIFUGAL FORCE) FOR TEN MINUTES, AT 16 DEGREES CELSIUS. THE CUSTOMER INDICATED QUALITY CONTROL (QC) AND HIGH SENSITIVITY (HS) SYSTEM CHECK PERFORMED WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. IN ADDITION, THE CUSTOMER PERFORMED A PATIENT CORRELATION STUDY BETWEEN THE TWO ACCESS® 2 SYSTEMS AND RESULTS PASSED WITHIN SPECIFICATIONS. NO SAMPLE INTEGRITY ISSUES WERE NOTED. THE INSTRUMENT WAS IN NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278735 ACCESS® ACCUTNI IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 336236

    Patients

    Seq Age Sex Outcome Treatment
    1