BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 3962237 · Received July 28, 2014

    Report

    Report Number
    2122870-2014-00547
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) ADJUSTED THE ULTRASONICS AND PRIMED THE INSTRUMENT. THE FSE VERIFIED THERE WERE NO FLUID LEAKS OR BUBBLING, VERIFIED AND ADJUSTED THE MIXING SPEED, VERIFIED THE VACUUM, THE SUBSTRATE, AND ASPIRATE VOLUME TESTS, CHECKED ALL PROBE ALIGNMENTS, AND VERIFIED THE ULTRASONIC ADJUSTMENT. THE FSE ADJUSTED AND LEVELED THE WASH STATION AND PERFORMED TEMPERATURE ADJUSTMENT. THE FSE NOTED FOLLOWING THE ADJUSTMENTS SYSTEM CHECK PASSED AND NO FURTHER EVIDENCE OF INTERMITTENT IND FLAGS WERE OBSERVED. THE FSE PERFORMED A SUCCESSFUL QUALITY CONTROL (QC). SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE ULTRASONIC SYSTEM. A DEFINITIVE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNWASHED PORTION OF SYSTEM CHECK DID NOT PASS, AND INTERMITTENT IND (INDETERMINATE) HYBRITECH-PROSTATE-SPECIFIC ANTIGEN (PSA) FLAGS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. ACTUAL PATIENT RESULTS WERE NOT GENERATED. THE IND FLAGGED RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT IMPACTED ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439568 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1