BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3131932 · Received May 29, 2013

    Report

    Report Number
    2122870-2013-00489
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REBUILT THE WASH PUMP, REPLACED THE LOWER SEAL AND O-RING, BELT, AND PUMP-TO-MANIFOLD O-RING. DURING FLUIDICS PRIMING, THE FSE DISCOVERED AIR IN THE WASH PUMP AND IN THE TUBING TO THE DISPENSE PROBES. THE FSE REPLACED THE WASH VALVE ROTOR TO RESOLVE THE ISSUE. THE FSE REPLACED THE MAIN PIPETTOR PROBE AND COMPLETED SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK; BOTH PASSED WITHIN SPECIFICATIONS. THE FSE COMPLETED A 25-REPLICATE PRECISION TEST TO VERIFY TROPONIN PRECISION WAS WITHIN SPECIFICATION. QUALITY CONTROL (QC) WAS WITHIN THE LABORATORY'S ESTABLISHED LIMITS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2013-00488.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS, NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION AND ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT, FOR THREE PATIENTS, ON TWO SEPARATE DAYS INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM UTILIZED IN CONJUNCTION WITH THE ACCESS ACCUTNI ASSAY AND CALIBRATOR . SUBSEQUENT TESTING OF THE PATIENT¿S SAMPLES, ON AN ALTERNATE ACCESS 2 INSTRUMENT, RECOVERED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. QUALITY CONTROL (QC) WAS WITHIN THE LABORATORY¿S ESTABLISHED LIMITS ON THE DATE OF THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THIS IS REPORT TWO OF TWO REFERENCING THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234407 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1