BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2392004 · Received December 29, 2011

    Report

    Report Number
    2122870-2011-06537
    Event Type
    Malfunction
    Date Received
    December 29, 2011
    Date of Event
    December 5, 2011
    Report Date
    December 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) VERIFIED THE TRANSDUCER VOLTAGE AND ALIGNMENTS. THE FSE ALSO DISCUSSED ENVIRONMENTAL TEMPERATURE ISSUES, QUALITY CONTROL AND STANDARD DEVIATION ISSUES WITH THE CUSTOMER. THE FSE ALSO NOTED CASE TEMPERATURE ERRORS IN THE INSTRUMENTS EVENT LOG. THE FSE REPLACED THE FLUIDICS TUBING FROM THE WASH BUFFER SUPPLY TO THE TRANSDUCER. UPON COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-06537, 2122870-2011-06550.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS HUMAN CHORIONIC GONADOTROPIN (BHCG) AND PROGESTERONE RESULTS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENTS. THIS REPORT IS ONE OF TWO AND REPRESENTS THE LOWER THAN EXPECTED PROGESTERONE RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PATIENT SAMPLES ON (B)(4) 2011. THE INITIAL, ERRONEOUS PROGESTERONE RESULTS WERE "0.00 NG/ML." UPON REPEAT TESTING ON THE SAME INSTRUMENT THE REPEAT PROGESTERONE RESULTS WERE HIGHER, WITHIN A HIGHER DIAGNOSTIC CATEGORY, AND CONSIDERED VALID. THE INITIAL PROGESTERONE RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, THERE WERE NO REPORTS OF ADVERSE EVENT, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE SAMPLES WERE SERUM SAMPLES AND WERE CENTRIFUGED PRIOR TO TESTING. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT SYSTEM CHECKS EXECUTED DURING THE TIMEFRAME OF THIS EVENT MET PUBLISHED SPECIFICATIONS. MULTIPLE ADDITIONAL INITIAL PATIENT PROGESTERONE RESULTS WERE PROVIDED BY THE CUSTOMER, HOWEVER, CONFIRMATORY REPEAT PROGESTERONE RESULTS WERE NOT GENERATED FOR ANY OTHER PATIENT AND HENCE THE INITIAL PATIENT RESULTS COULD NOT BE CONFIRMED AS ERRONEOUS. ADDITIONAL ASSAY TEST RESULTS FOR THESE PATIENTS ARE NOT IN QUESTION TO DATE.

    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 PROGESTERONE REAGENT