BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 754804 · Received October 18, 2005

    Report

    Report Number
    2122870-2005-00157
    Event Type
    Other
    Date Received
    October 18, 2005
    Date of Event
    September 21, 2005
    Report Date
    October 18, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT QC WAS PERFORMED PRIOR TO THE EVENT AND WAS WITHIN THEIR RANGES. SYSTMEM CHECK RAN ON 09/19/05 WAS WITHIN SPECIFICATIONS. THE CUSTOMER INDICATED THAT THEY HAVE HAD SEVERAL EVENTS POSTED TO THE EVENT LOG FOR: (PRECISION PUMP, QNS, ULTRASONIC PIPETTOR AND SAMPLE CAROUSEL MOTION ERRORS). IT IS UNCLEAR IF THE LOW PSA RESULTS WERE FLAGGED AS THE CUSTOMER DID NOT PROVIDE TRAY REPORTS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER LAB. THE FSE REVIEWED THE EVENT LOG AND FOUND MULTIPLE POSTINGS FOR INSTRUMENT MOTION FAILURES AND ULTRASONIC SURFACE DETECT FAILURES. THE FSE INSPECTED THE INSTRUMENT AND DISCOVERED A SIGNIFICANT KINK IN THE SUBSTRATE PROBE TUBING. THE FSE REPLACED THE SUBSTRATE PROBE TUBING. THE FSE FOUND A LOOSE SCREW TO HOME FLAG ATTACHMENT POINT. THE FSE TIGHTENED THE SCREW. THE FSE REPLACED PIPETTOR TIP, RE-ALIGNED MAIN PIPETTOR AND VERIFIED THE ULTRASONIC. THE FSE PERFORMED A SYSTEM DIAGNOSTIC TEST AND VERIFIED THAT THE INSTRUMENT WAS WORKING WITHIN SPECIFICATIONS. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING ERRONEOUSLY LOW PSA RESULTS ON THREE DIFFERENT PATIENT SAMPLES THAT WERE GENERATED BY THE ACCESS 2 INSTRUMENT. THE CUSTOMER INDICATED THAT THE PSA RESULTS WERE 0.1NG/ML FOR PATIENT A, 0.7NG/ML FOR PATIENT B, AND ",0.1NG/ML FOR PATIENT C. THE PSA RESULTS WERE NOT REPORTED OUT OF THE LAB. THE CUSTOMER INDICATED THAT THE PATIENT'S (A,B,C) ORIGINAL SAMPLES WERE RETESTED FOR PSA ON ANOTHER INSTRUMENT IN THEIR LAB. THE PSA RESULTS OBTAINED FROM ANOTHER INSTRUMENT WERE: 6.8NG/DL FOR PATIENT A, 37.8NG/ML FOR PATIENT B, AND 8.5NG/ML FOR PATIENT C. THE CUSTOMER INDICATED THAT THEY HAVE RECEIVED NO REPORTS OF THE CHANGE TO PATIENT TREATMENT THAT CAN BE ATTRIBUTED TO OR CONNECTED WITH 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA