BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM (REFURBISHED)

    MDR report key: 2132121 · Received June 17, 2011

    Report

    Report Number
    2122870-2011-01903
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ONLY INDICATED THAT THE SAMPLES ARE COLLECTED IN PLASTIC BLOOD TUBES WITH GEL. CENTRIFUGATION DATA WAS NOT SUPPLIED. SYSTEM CHECKS PERFORMED ON (B)(6) 2011 AND (B)(6) 2011 RESULTED WITHIN SPECIFICATIONS. THREE LEVELS OF PSA QC RESULTED WITHIN SPECIFICATIONS DURING THE TIME OF THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND (B)(4) 2011 FOR THIS EVENT. THE FSE NOTED THAT THE MIXER SPEED WAS AT 2,450 WHICH SHOULD BE AT LEAST 25,003 (UNIT OF MEASURE NOT SPECIFIED). THE FSE REPLACED THE 14T BEARINGS, PERI-TUBING, AND ASPIRATE PROBES. THE FSE NOTED THAT THE 14T BEARINGS WERE REPLACED DUE TO THE MIXER SPEED BEING TOO LOW, WHICH WAS THE CAUSE OF THE PSA RESULTS TO BE ERRONEOUSLY LOW. THE FSE PERFORMED PSA CALIBRATION AND 50 POINT PRECISION RUN WHICH RESULTED WITHIN EXPECTATIONS. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. HARDWARE IS THE ROOT CAUSE OF THIS EVENT. NO FURTHER PROBLEMS OCCURRED AFTER SERVICE WAS PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY LOW HYB-PSA RESULTS WITHIN THE NORMAL REFERENCE RANGE FOR TWO (2) PATIENTS THAT WERE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. UPON REPEAT TESTING, RESULTS WERE ABOVE THE ASSAY'S NORMAL REFERENCE RANGE. IT IS UNKNOWN IF PATIENT TREATMENT WAS AFFECTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM (REFURBISHED) DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. ACCESS® 2 (REFURBISHED) NA

    Patients

    Seq Age Sex Outcome Treatment
    1