BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1901310 · Received November 17, 2010

    Report

    Report Number
    2122870-2010-00737
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN A 4ML GREEN TOP HEPARIN PLASMA TUBE. THE SPECIMEN WAS CENTRIFUGED AT 3,800RPM FOR 10 MINUTES. PER CUSTOMER, THERE WAS NO VISIBLE FIBRIN. CUSTOMER RUNS TWO QC LEVELS ONCE EVERY 24 HOURS AND STATED THAT QC HAS BEEN RECOVERING WITHIN ESTABLISHED RANGES. A SYSTEM CHECK RUN ON (B)(6) 2010 PASSED ALL SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE REPLACED SOME PARTS, CLEANED HARDWARE COMPONENTS, AND CHECKED ALL ALIGNMENTS, TEMPERATURE AND VOLTAGES. THE FSE REBUILT PRECISION PUMP AND WASH PUMP. THE FSE PERFORMED A DIAGNOSTIC TEST AND RAN A 50 TEST PRECISION ON LOW LEVEL QC. RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. HARDWARE MAY HAVE CONTRIBUTED TO THIS EVENT; HOWEVER, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING AN ERRONEOUSLY HIGH TROPONIN (ACCUTNI) RESULT, ABOVE THE AMI CUT OFF, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT SAMPLE. THE RESULT WAS REPORTED OUT OF THE LAB AND WAS QUESTIONED AS NOT MATCHING THE PATIENT'S CLINICAL PRESENTATION. REPEAT TESTING ON THE SAME INSTRUMENT RESULTED WITHIN THE NORMAL REFERENCE RANGE. A CORRECTED REPORT WAS SENT. CUSTOMER WAS NOT MADE AWARE OF ANY INJURY OR CHANGE IN TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1