BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2433805 · Received January 31, 2012

    Report

    Report Number
    2122870-2012-00171
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JLS
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COUTLER INC. SERVICE WAS DISPATCHED TO THE SITE AND CONFIRMED THE SYSTEM WAS OPERATING WITHIN SPECIFICATIONS. NO CAUSE FOR THIS EVENT HAS BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PROGESTERONE RESULTS, DISCREPANT TO PATIENT CLINICAL DIAGNOSIS, HAD BEEN OBTAINED FROM AN ACCESS 2 IMMUNOASSAY SYSTEM FOR AN UNSPECIFIED NUMBER OF NORMAL, PREGNANT OR IN-VITRO FERTILIZATION PATIENTS' SAMPLES. THE PROGESTERONE RESULTS WERE REPORTED OUT OF THE LABORATORY AND IT IS UNKNOWN IF THERE WAS PATIENT INJURIES REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT DUE TO THESE DISCREPANCIES. THE SAMPLES WERE COLLECTED IN SERUM TUBES. BECKMAN COULTER INC. ASSESSMENT OF SUPPLIED DATA INDICATES THAT THERE MAY HAVE BEEN BIAS BETWEEN COLLECTION TUBE MANUFACTURERS. IT IS UNKNOWN AS TO WHETHER THE DATA PROVIDED BY THE CUSTOMER WAS ASSOCIATED WITH ACTUAL, REPORTED PATIENT RESULTS OR RATHER INVESTIGATORY DATA. NO QUALITY CONTROL (QC) DATA WAS SUPPLIED BY THE CUSTOMER WITH THE EXCEPTION OF CORRELATION DATA. THIS DATA DID NOT SUPPLY DETAILS OF THE CUSTOMER'S DAY TO DAY QC RECOVERY. NO PATIENT INFORMATION, ADDITIONAL SYSTEM INFORMATION, ADDITIONAL SAMPLE COLLECTION/HANDLING INFORMATION OR PATIENT RESULTS WERE PROVIDED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS PROGESTERONE REAGENT