BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2132164 · Received June 17, 2011

    Report

    Report Number
    2122870-2011-01906
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES ARE COLLECTED IN PLASTIC BD LITHIUM HEPARIN TUBES WITH GEL. CENTRIFUGATION DATA WAS NOT SUPPLIED. PER THE CUSTOMER, TWO LEVELS OF ACCUTNI QC RESULTS WITHIN THE CUSTOMER'S ESTABLISHED RANGES ON THE DAY OF THE EVENT. SYSTEM CHECKS PERFORMED ON (B)(6) 2011 MET SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE TROUBLESHOT THE ULTRASONIC VOLTAGE. THE FSE REPLACED THE PIPETTOR TIP AND VERIFIED VOLTAGE. THE FSE ALSO VERIFIED THE VACUUM SYSTEM, THE MIXER BELT SPEED, AND CALIBRATED THE INCUBATOR BELT. THE FSE RAN A SYSTEM CHECK AND A HIGH SENSITIVITY (HS) SYSTEM CHECK, WHICH BOTH PASSED. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. A ROOT CAUSE FOR THIS EVENT WAS NOT DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING TROPONIN (ACCUTNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE FOR ONE (1) PATIENT WHICH EXCEEDED THE ASSAY'S TOTAL IMPRECISION CLAIM OF 20%, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER DID NOT REPORT AFFECT TO THE END USER OR PATIENT RESULTS ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1