BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2514869 · Received April 3, 2012

    Report

    Report Number
    2122870-2012-00872
    Event Type
    Malfunction
    Date Received
    April 3, 2012
    Date of Event
    February 24, 2012
    Report Date
    March 14, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LTJ
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING OF THE CUSTOMER-SUPPLIED PATIENT SAMPLE AT BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY CONFIRMED THE CAUSE OF THE ERRONEOUS RESULT WAS DUE TO THE EXISTENCE OF A PATIENT SOURCE INTERFERENT IN THE SAMPLE. PRODUCT LABELING STATES: FOR ASSAYS EMPLOYING ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HETEROPHILE ANTIBODIES IN THE PATIENT SAMPLE. PATIENTS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS OR HAVE RECEIVED IMMUNOTHERAPY OR DIAGNOSTIC PROCEDURES UTILIZING IMMUNOGLOBULINS OR IMMUNOGLOBULIN FRAGMENTS MAY PRODUCE ANTIBODIES, E.G. HUMAN ANTI-MOUSE ANTIBODIES (HAMA), THAT INTERFERE WITH IMMUNOASSAYS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES SUCH AS HUMAN ANTI-GOAT ANTIBODIES MAY BE PRESENT IN PATIENT SAMPLES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. CAREFULLY EVALUATE THE RESULTS OF PATIENTS SUSPECTED OF HAVING THESE ANTIBODIES.

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. THE PATIENT SAMPLE WAS RETURNED TO BECKMAN COULTER INC. CUSTOMER PRODUCT LINE SUPPORT FOR INTERFERENCE TESTING. THE RESULTS OF TESTING ARE NOT YET AVAILABLE. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2012-00872 AND 2122870-2012-00873.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A HIGHER THAN EXPECTED HYBRITECH PROSTATE SPECIFIC ANTIGEN (HYB PSA) RESULT WAS GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT ON TWO DAYS. THIS REPORT REPRESENTS THE INITIAL, HIGHER THAN EXPECTED HYB PSA RESULT, WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY, WHICH WAS GENERATED ON (B)(6) 2012. REPEAT TESTING ON THE SAME INSTRUMENT GENERATED A SIMILAR HYB PSA RESULT. THE INITIAL, ELEVATED HYB PSA RESULT WAS REPORTED OUTSIDE OF THE LABORATORY HOWEVER THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. A SUBSEQUENT, SAME-PATIENT SAMPLE WAS TESTED USING AN ALTERNATIVE METHODOLOGY, AND THE HYB PSA RESULT WAS LOWER AND REGARDED AS VALID. INSTRUMENT ASSAY QUALITY CONTROL RESULTS DURING THE TIMEFRAME OF THE EVENT WERE WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS. SYSTEM CHECKS AND A CALIBRATION PERFORMED DURING THE TIMEFRAME OF THIS EVENT ALSO GENERATED ACCEPTABLE RESULTS. NO SAMPLE HANDLING/COLLECTION INFORMATION WAS PROVIDED BY THE CUSTOMER.

    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 63 YR ACCESS HYBRITECH PSA REAGENT