BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172395 · Received July 22, 2011

    Report

    Report Number
    2122870-2011-02369
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LTJ
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 A HIGHER THAN EXPECTED HYBRITECH PROSTATE SPECIFIC ANTIGEN (HYB-PSA) RESULT, ABOVE THE NORMAL REFERENCE RANGE, WAS GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT SAMPLE. THE RESULT WAS REPORTED OUTSIDE THE LABORATORY AND WAS QUESTIONED BY THE PHYSICIAN. IT WAS REPEATED BY AN OUTSIDE REFERENCE LABORATORY. THE REPEAT RESULT WAS LOWER, BUT STILL ABOVE THE NORMAL REFERENCE RANGE. ALTHOUGH THE INITIAL, ERRONEOUS PSA RESULT WAS RELEASED FROM THE LABORATORY, THERE WAS NO REPORTED DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. INSTRUMENT PSA QUALITY CONTROL (QC) RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES AT THE TIME OF THE EVENT. AN INSTRUMENT SYSTEM CHECK PERFORMED PRIOR TO THE EVENT GENERATED ACCEPTABLE RESULTS. THE CUSTOMER WAS NOT QUESTIONING ANY OTHER INSTRUMENT ASSAY RESULTS. THE SAMPLE WAS COLLECTED IN A GEL SEPARATOR TUBE, AND WAS CENTRIFUGED PRIOR TO TESTING. THE SAMPLE APPEARED "NORMAL" WITH NO VISIBLE ABNORMALITIES. REPEAT TESTING WAS PERFORMED WITHIN 3 HOURS OF INITIAL TESTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR ACCESS HYBRITECH PSA REAGENT