BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ SST TUBES

    MDR report key: 9178510 · Received October 11, 2019

    Report

    Report Number
    2243072-2019-02263
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    September 26, 2019
    Report Date
    March 23, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY : BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE OF THE UNSPECIFIED BD¿ SST TUBES THERE IS INTERFERING SUBSTANCES IN SST TUBES THAT FALSELY ELEVATE TRIIODOTHYRONINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ARTICLE INTERFERENCES FROM BLOOD COLLECTION TUBE COMPONENTS ON CLINICAL CHEMISTRY ASSAYS (FEBRUARY 2014) BY RAFFICK A.R. BOWEN AND ALAN T. REMALEY STATES THAT PUBLICATION EFFECT OF BLOOD COLLECTION TUBES ON TOTAL TRIIODOTHYRONINE AND OTHER LABORATORY ASSAYS, PUBLISHED 2005 BY RAFFICK A.R. BOWEN, YUNG CHAN, JOSHUA COHEN, NADJA N. REHAK, GLEN L. HORTIN, GYORGY CSAKO, ALAN T. REMALEY ¿DEMONSTRATED THAT THE NONIONIC POLYDIMETHYLSILOXANE-POLYETHYLENE OXIDE AND POLYPROPYLENE OXIDE GRAFT COPOLYMER SF, SILWET¿ L-720 IN BD SST¿ TUBES FALSELY ELEVATES TRIIODOTHYRONINE IN A DOSE-DEPENDENT MANNER BY CAUSING THE DESORPTION OF CAPTURED ANTIBODIES FROM THE SOLID PHASE USED IN IMMUNOASSAYS. COMPETITIVE IMMUNOASSAYS (E.G., VITAMIN B12) AND NON-COMPETITIVE IMMUNOASSAYS (E.G., CANCER ANTIGEN 15-3) ARE ALSO AFFECTED BY SILWET L-720, BUT THE MECHANISM IS UNCLEAR¿.

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN. IT WAS REPORTED THAT AFTER USE OF THE UNSPECIFIED BD¿ SST TUBES THERE IS INTERFERING SUBSTANCES IN SST TUBES THAT FALSELY ELEVATE TRIIODOTHYRONINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ARTICLE INTERFERENCES FROM BLOOD COLLECTION TUBE COMPONENTS ON CLINICAL CHEMISTRY ASSAYS ((B)(6) 2014) BY (B)(6) STATES THAT PUBLICATION EFFECT OF BLOOD COLLECTION TUBES ON TOTAL TRIIODOTHYRONINE AND OTHER LABORATORY ASSAYS, PUBLISHED 2005 BY (B)(6). REMALEY ¿DEMONSTRATED THAT THE NONIONIC POLYDIMETHYLSILOXANE-POLYETHYLENE OXIDE AND POLYPROPYLENE OXIDE GRAFT COPOLYMER SF, SILWET¿ L-720 IN BD SST¿ TUBES FALSELY ELEVATES TRIIODOTHYRONINE IN A DOSE-DEPENDENT MANNER BY CAUSING THE DESORPTION OF CAPTURED ANTIBODIES FROM THE SOLID PHASE USED IN IMMUNOASSAYS. COMPETITIVE IMMUNOASSAYS (E.G., VITAMIN B12) AND NON-COMPETITIVE IMMUNOASSAYS (E.G., CANCER ANTIGEN 15-3) ARE ALSO AFFECTED BY SILWET L-720, BUT THE MECHANISM IS UNCLEAR¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976970 UNSPECIFIED BD¿ SST TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other