BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1369584 · Received January 30, 2009

    Report

    Report Number
    2122870-2009-00035
    Event Type
    Malfunction
    Date Received
    January 30, 2009
    Date of Event
    January 9, 2009
    Report Date
    January 30, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    NDR
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A SERUM TUBE AND IT WAS CENTRIFUGED AT 3,500 RPM FOR 10 MINUTES. THIS IS THE ONLY RESULT AND ASSAY IN QUESTION AT THIS TIME. QC WAS RECOVERING WITHIN EXPECTED RANGES PRIOR TO AND ON THE DAY OF EVENT. A SYSTEM CHECK PERFORMED ON 01/12/09 WAS WITHIN THE PUBLISHED SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE REPLACED THE TRANSDUCER. THE FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES, AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. PER FSE, THE TRANSDUCER VOLTAGE WAS NOT HOLDING AT THE CORRECT READING WHILE SONICATING THE PARTICLES WHILE ASPIRATING. IT WAS INTERMITTENT WHICH COULD EXPLAIN WHY NOT ALL TESTING WAS AFFECTED. ALSO, NOT ALL ASSAYS ARE SENSITIVE TO SONICATING PROBLEMS. THE FSE STATED THIS ISSUE WAS THE ROOT CAUSE FOR THIS EVENT. EVEN THOUGH THE LOW INHIBIN A RESULT OBTAINED IS UNLIKELY TO BE THE BASIS TO INITIATE OR WITHHOLD TREATMENT, IN THIS EVENT THE HARDWARE FAILURE MAY HAVE AFFECTED OTHER PIVOTAL ASSAYS. ERRONEOUS RESULTS OF A PIVOTAL ASSAY MAY CONTRIBUTE TO SERIOUS INJURY TO THE PT. HARDWARE ISSUE ADDRESSED BY THE FSE LIKELY CONTRIBUTED TO THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A LOWER THAN EXPECTED RESULT FOR INHIBIN A THAT WAS GENERATED BY THE ACCESS 2 INSTRUMENT FOR ONE PT. THE INITIAL INHIBIN A RESULT WAS 25.0PG/ML. THE RESULT WAS NOT REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLE WAS RE-TESTED TWICE AND RESULTS OF 104.7PG/ML AND 102.3PG/ML WERE OBTAINED, RESPECTIVELY. THE RESULT OF 102.3PG/ML WAS REPORTED OUT OF THE LAB. THERE WAS NO EFFECT TO PT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA