BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3011828 · Received March 19, 2013

    Report

    Report Number
    2122870-2013-00315
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED A WASH VALVE MOTION ERROR ON THE EVENT LOG AND DISCOVERED EXCESSIVE AIR IN THE WASH BUFFER LINES. THE FSE REMOVED AND CLEANED THE WASH VALVE ASSEMBLY WITH DEIONIZED (DI) WATER AND PRIMED THE DISPENSE PROBES. THE FSE COMPLETED SYSTEM CHECK AND PREVENTATIVE MAINTENANCE (PM) MINOR AND PERFORMED A 50-REPLICATE PRECISION RUN FOR THE TROPONIN I ASSAY. THE CUSTOMER COMPLETED ALL ASSAY QUALITY CONTROL (QC). 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. PATIENT SAMPLES WERE COLLECTED IN 13 MM BECTON DICKINSON (BD) LITHIUM HEPARIN GEL SEPARATOR TUBES AND CENTRIFUGED FOR EIGHT MINUTES AT ROOM TEMPERATURE. THE SAMPLES WERE TESTED BY ALIQUOTTING THE SAMPLE INTO AN INSERT CUP, PLACED IN THE PRIMARY TUBE. THE LABORATORY PERFORMS QUALITY CONTROL (QC) EVERY 24 HOURS. THE CUSTOMER STATED QC WAS IN RANGE AT THE TIME OF THE EVENT. SYSTEM CHECK, PERFORMED ON (B)(6) 2013, PASSED WITHIN SPECIFICATION. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2013-00314, 2122870-2013-00315, 2122870-2013-00316.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS TROPONIN I (ACCESS ACCUTNI) AND CREATINE KINASE-MB (CK-MB) RESULTS, FOR THREE PATIENTS, ON THREE SEPARATE DAYS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH THE ACCESS ACCUTNI AND ACCESS CK-MB ASSAYS AND CALIBRATORS. SUBSEQUENT ANALYSES OF THE PATIENTS' SAMPLES, ON AN ALTERNATE ACCESS 2 SYSTEM, RECOVERED NEGATIVE RESULTS. TWO OF THE PATIENTS' RESULTS WERE RELEASED OUT OF THE LABORATORY. THE CUSTOMER IS UNCERTAIN IF PATIENT TREATMENT WAS IMPACTED. THERE HAS BEEN NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THIS REPORT REFERENCES THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113858 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1