BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2122595 · Received June 14, 2011

    Report

    Report Number
    2122870-2011-01864
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    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

    SERVICE WAS DISPATCHED ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE VERTICAL BEARINGS AND DISPENSE PROBE 5 LOCKING MECHANISM. THEY RE-SOLDERED THE MOTOR SOLDER CONNECTIONS AND COVERED IN HEAT SHRINK TUBING. THEY OBSERVED THAT THE WASH TOWER ACRYLIC BLOCK WAS SHATTERING AT THE SCREW CONNECTIONS AND REPLACED IT. THEY ALSO REPLACED THE OBSTRUCTION DETECTION ASSEMBLY AND GENERATED A SUCCESSFUL REFERENCE CURVE. UPCOMING SCHEDULED PREVENTIVE MAINTENANCE WAS PERFORMED. PARTS WERE REPLACED PER STANDARD OPERATING PROCEDURE. SUBSEQUENT SYSTEM CHECKS, HIGH SENSITIVITY SYSTEM CHECKS, AND QUALITY CONTROL (QC) ASSESSMENTS WERE PERFORMED AND MET ACCEPTABLE SPECIFICATIONS. ALTHOUGH THE INSTRUMENT WAS REPAIRED AND RETURNED INTO SERVICE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE EXPERIENCING AN APPROXIMATELY 10% INCREASE IN PATIENT INHININ A RESULTS GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM BETWEEN (B)(6) 2011. INHININ A RESULTS WERE REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN HOW MANY, IF ANY, WERE ERRONEOUS. IT IS ALSO UNKNOWN WHETHER THERE WERE ANY MODIFICATIONS TO PATIENT TREATMENTS MADE, BASED UPON THESE RESULTS. THERE WERE NO REPORTS OF PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT. SYSTEM CHECKS DURING THE TIMEFRAME OF THIS EVENT MET PUBLISHED SPECIFICATION. THE CUSTOMER DOES NOT UTILIZE A PATIENT POOL FOR QUALITY CONTROL (QC) RESULTS. LOW LEVEL QC RESULTS INDICATE A 1 STANDARD DEVIATION UPWARD SHIFT BETWEEN (B)(6) 2011. THERE WERE NO REAGENT OR CALIBRATOR LOT CHANGES DURING THE TIMEFRAME OF THE EVENT. A NEW QC LOT (# (B)(4)) WAS EVALUATED IN (B)(6) 2011 AND IMPLEMENTED IN (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS INHIBIN A REAGANT