BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1971930 · Received January 27, 2011

    Report

    Report Number
    2122870-2011-00149
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 30, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS WERE OBTAINED FROM SERUM SAMPLES THAT WERE STORED FROZEN PRIOR TO ANALYSIS. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(4) 2010 WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE MADE ADJUSTMENTS TO THE TRANSDUCER VOLTAGE. THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK; NO ISSUES WERE NOTED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING LOWER THAN EXPECTED INHIBIN A RESULTS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR FIVE PATIENTS. SUBSEQUENT TESTING PRODUCED HIGHER RESULTS IN A DIFFERENT CLINICAL CATEGORY FOR ALL FIVE PATIENTS. THE LOW RESULTS WERE NOT REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT 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 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1