BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3062289 · Received April 16, 2013

    Report

    Report Number
    2122870-2013-00391
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPORTED AN ISSUE WITH THE INSTRUMENT PIPETTOR AND PERFORMED SETTING ADJUSTMENT. THE FSE OBSERVED THE ULTRASONIC VOLTAGE SETTING WAS UNSTABLE AND RESET THE VOLTAGE TO THE APPROPRIATE SETTING OF 197V. THE FSE PERFORMED A 10-REPLICATE PRECISION TEST AT LOW LEVEL AND LEVEL 3, UTILIZING QC MATERIAL, AND PRODUCED PRECISE RESULTS WITHIN THE LABELED PRECISION LIMITS. ON (B)(4) 2013, THE FSE RETURNED TO FACILITY AND OBSERVED PIPETTOR ISSUE AND THE VOLTAGE WAS UNSTABLE. THE FSE REPLACED THE PIPETTE AND TRANSDUCER AND SUCCESSFULLY COMPLETED SYSTEM CHECK, HIGH SENSITIVITY SYSTEM CHECK, AND PRECISION TESTS. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT, FOR TWO INPATIENTS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH THE ACCESS ACCUTNI ASSAY. THE CUSTOMER REANALYZES ANY PATIENT SAMPLES WITH ELEVATED TROPONIN I RESULTS. SUBSEQUENT ANALYSES OF THE PATIENTS' SAMPLES, ON THE SAME INSTRUMENT, PRODUCED ELEVATED AND NORMAL TROPONIN I RESULTS. THE ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY. HOWEVER, THE PHYSICIANS REPORTED THERE WAS NO PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. QUALITY CONTROL (QC) IS PERFORMED EVERY EIGHT HOURS AT TWO CONTROL LEVELS. QC WAS WITHIN LIMITS AFTER ASSAY RECALIBRATION. SYSTEM CHECKS PASSED ON THE DAY OF THE EVENT AFTER A SCHEDULED PREVENTIVE MAINTENANCE (PM) WAS COMPLETED. PATIENT SAMPLES ARE COLLECTED IN 13X75 MM PLASTIC SEPARATION TUBES (PST) WITH GEL AND CENTRIFUGED AT 5,000 RPM (ROTATIONS PER MINUTE) FOR FIVE MINUTES IN A SWING-BUCKET CENTRIFUGE, AT ROOM TEMPERATURE. THE AFFECTED SAMPLES WERE OF ADEQUATE VOLUME AND WERE ANALYZED AS PRIMARY TUBES. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162489 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1