BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS HBC AB 2 X 50 TESTS

    MDR report key: 2171169 · Received July 1, 2011

    Report

    Report Number
    2122870-2011-02086
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    January 31, 2008
    Report Date
    February 15, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LOM
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE AFFILIATE REPORTED THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THE CUSTOMER STATED LEVEL 2 QUALITY CONTROL (QC) ON REAGENT PACK SERIAL NUMBER (B)(4) WAS OUT OF RANGE (LOW) MULTIPLE TIMES. QC WAS RETESTED ON REAGENT PACK SERIAL NUMBER (B)(4) AND PRODUCED THE EXPECTED REACTIVE RESULTS. THE REAGENT PACK IN QUESTION, SERIAL NUMBER (B)(4) WAS SENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) LAB IN (B)(4) FOR INVESTIGATION. THE PACK WAS NOT PACKAGED TO PREVENT LEAKING. DUE TO THE PACK LEAKING, AN INVESTIGATION OF THE PACK COULD NOT BE PERFORMED. CPLS DID REVIEW THE DIAGNOSTIC TO DISK INFO WHICH DID NOT CONFIRM THE CUSTOMERS QC OUT OF RANGE RESULTS; TWO PTS' RESULTS FROM REAGENT PACK SERIAL NUMBER (B)(4) DID NOT DUPLICATE THE RESULTS PERFORMED ON SERIAL NUMBER (B)(4). CPLS ALSO IDENTIFIED THE CUSTOMER WAS RUNNING ON AN EXPIRED CALIBRATION CURVE. CUSTOMER PRODUCT LINE SUPPORT (CPLS) LAB IN EUROPE TESTED THE PT SAMPLE AND PRODUCED A REACTIVE RESULT. THE RESULT WAS NEGATIVE ON A THIRD METHOD (ROCHE). HOWEVER, HETEROPHILE TESTING LOWERED SIGNIFICANTLY INDICATING THE PRESENCE OF INTERFERING SUBSTANCES IN THE PT SAMPLE. HETEROPHILE INTERFERENCE IS THE MOST LIKELY CAUSE OF THE ERRONEOUS RESULTS. PRODUCT LABELING: THE ASSAYS EMPLOYING ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HETEROPHILE ANTIBODIES IN THE PT SAMPLE. PTS 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 PT SAMPLES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. CAREFULLY EVALUATE THE RESULTS OF PTS SUSPECTED OF HAVING THESE ANTIBODIES. THE ACCESS HBCAB RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, DATA FROM ADD'L TESTS, AND OTHER APPROPRIATE INFO. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2011-02087.

    Description of Event or Problem · 1

    THE AFFILIATE ALLEGED THE CUSTOMER REPORTED TWO ERRONEOUS NON-REACTIVE (B)(6) RESULTS WHICH REPEATED REACTIVE ON TWO PT SAMPLES INVOLVING ACCESS HBC AB 2 X 50 TESTS. THIS REPORT REFERS TO PT NUMBER ONE. THE RESULTS IN QUESTION WERE PRODUCED FROM THE SAME REAGENT PACK. THE RESULTS WERE DISCORDANT TO AN ALTERNATE METHODOLOGY, WHICH WAS NEGATIVE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. THERE WAS NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER SUPPLIED BECKMAN COULTER, INC. IN (B)(4) WITH THE PT SAMPLE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS HBC AB 2 X 50 TESTS HEPATITIS B CORE ANTIBODY LOM BECKMAN COULTER, INC. NA 794351

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS 2 IMMUNOASSAY SYSTEM