BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® ACCUTNI?

    MDR report key: 3251101 · Received July 29, 2013

    Report

    Report Number
    2122870-2013-00642
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 5, 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. THE FIELD SERVICE ENGINEER (FSE) COMPLETED 150 SAMPLES TESTING USING WASH BUFFER AND POOLED SERUM WITH A KNOWN RESULT OF 0.001 NG/ML AS SAMPLES. THE VALUES RANGED FROM 0.00-0.014 NG/ML. THE FSE NOTED THE INCUBATOR BELT WAS NOISY AND REPLACED THE INCUBATOR BELT AND BEARINGS. THE FSE PERFORMED ALL ALIGNMENTS, CLEANED THE WASH WHEEL AND VERIFIED ALL WASH WHEEL BEARINGS. THE FSE COMPLETED A PASSING HIGH SENSITIVITY SYSTEM CHECK AND SYSTEM CHECK. THE FSE COMPLETED ANOTHER 50 SAMPLES TESTING USING WASH BUFFER AS SAMPLES AND PRODUCED RESULTS RANGING FROM 0.00-0.008 NG/ML. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. A DEFINITIVE CAUSE OF THE EVENT IS UNKNOWN. THIS MEDWATCH REPORT IS RELATED TO 2122870-2013-00641.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE DISCREPANT TROPONIN I (ACCESS ACCUTNI) RESULTS, FOR MULTIPLE PATIENTS, INVOLVING THE ACCESS ACCUTNI ASSAY USED IN CONJUNCTION WITH THE ACCESS 2 IMMUNOASSAY SYSTEM AND ACCESS ACCUTNI CALIBRATOR. IT IS UNKNOWN IF ALL OF THE PATIENTS¿ RESULTS WERE RELEASED FROM THE LABORATORY. THE CUSTOMER STATED THREE CORRECTIVE REPORTS WERE ISSUED TO THE HOSPITAL. IT IS UNKNOWN IF PATIENT CARE WAS IMPACTED. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED THE TROPONIN ANALYSIS WAS SET UP TO REFLEX IF THE RESULT WAS ELEVATED. THE PATIENTS¿ SAMPLES WERE COLLECTED IN LITHIUM HEPARIN TUBES AND CENTRIFUGED AT 3,500 RPM (ROTATIONS PER MINUTE) FOR FIVE MINUTES FOLLOWING SAMPLE COLLECTION; PATIENT SAMPLES ARE NOT STORED. ALL LEVELS OF QUALITY CONTROL (QC) ARE PERFORMED DAILY AND WERE WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. CALIBRATIONS AND SYSTEM CHECK PASSED WITHIN THE ACCEPTABLE RANGE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THIS IS REPORT TWO OF TWO REFERENCING THE PATIENTS ON THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353719 ACCESS® ACCUTNI? IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 328940

    Patients

    Seq Age Sex Outcome Treatment
    1