BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3760226 · Received April 18, 2014

    Report

    Report Number
    2122870-2014-00276
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 23, 2014
    Report Date
    March 26, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) ADJUSTED THE MIXER SPEED FROM 2,450 RPM TO 2,500 RPM (ROTATIONS PER MINUTE). THE FSE NOTED THE ULTRASONIC VOLTAGE WAS AT 228 VOLTS AND ADJUSTED IT TO 197 VOLTS (INCORRECT VOLTAGE MAY CAUSE INSUFFICIENT MIXING OF THE MAGNETIC PARTICLES). THE FSE PERFORMED A PASSING SYSTEM CHECK, HIGH SENSITIVITY SYSTEM CHECK, AND 15-REPLICATE PRECISION TEST. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, SYSTEM HARDWARE, ASSOCIATED WITH THE TRANSDUCER VOLTAGE, IS THE LIKELY CAUSE OF THE EVENT. BECKMAN COULTER CONTINUES TO TRACK AND TREND ANY INCIDENT RELATED TO THIS ISSUE. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2014-00274, 2122870-2014-00275, 2122870-2014-00276, 2122870-2014-00277.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAILED CALIBRATIONS AND IND (INDETERMINATE) FLAGGED ACCESS® ACCUTNI+3 RESULTS, FOR FIVE PATIENTS, ON SEPARATE EVENT DATES, INVOLVING THE ACCESS® 2 IMMUNOASSAY SYSTEM. THE IND RESULTS (NON-NUMERICAL) WERE NOT RELEASED FROM THE LABORATORY. THE CUSTOMER REANALYZED THE PATIENTS' SAMPLES ON THE ALTERNATE ACCESS® 2 INSTRUMENT AND OBTAINED LOWER RESULTS. THERE WAS NO PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237143 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1