BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® ACCUTNI?

    MDR report key: 3133894 · Received May 29, 2013

    Report

    Report Number
    2122870-2013-00492
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 28, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THE ACCESS ACCUTNI DEVICE WAS RETURNED FOR EVALUATION. A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRATIC TROPONIN I (ACCESS ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION, FOR ONE PATIENT, INVOLVING THE ACCESS ACCUTNI ASSAY UTILIZED IN CONJUNCTION WITH THE ACCESS 2 IMMUNOASSAY SYSTEM AND THE ACCESS ACCUTNI CALIBRATOR. SAMPLE REANALYSIS, ON AN ALTERNATE ACCESS 2 SYSTEM, RECOVERED RESULTS WITHIN THE RISK STRATIFICATION RANGE FOR ALL REPLICATES. THE ORIGINAL RESULT WAS RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. QUALITY CONTROL (QC) INDICATES ALL THREE LEVELS OF QC WERE WITHIN THE LABORATORY¿S RANGES FOR 30 DAYS PRIOR TO THE EVENT. SYSTEM CHECK, PERFORMED ON (B)(4) 2013, WAS WITHIN SPECIFICATIONS. THREE CALIBRATIONS WERE PROVIDED AND ALL PASSED WITH ACCEPTABLE RELATIVE LIGHT UNITS (RLU) AND PERCENT COEFFICIENT OF VARIATION (%CV). THE INSTRUMENT WAS IN OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234933 ACCESS® ACCUTNI? IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1