BEUDAMED
    FDA Adverse Event Death Summary report: N

    XTAG RESPIRATORY VIRAL PANEL FAST

    MDR report key: 2621413 · Received June 11, 2012

    Report

    Report Number
    3002777243-2012-00001
    Event Type
    Death
    Date Received
    June 11, 2012
    Date of Event
    May 15, 2012
    Report Date
    June 13, 2012
    Manufacturer
    LUMINEX MOLECULAR DIAGNOSTICS, INC.
    Product Code
    OCC
    PMA / PMN Number
    K103776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOR CASE #1 (XTAG RVP FAST TEST RESULTS NOT REPORTED TO THE PHYSICIAN), CUSTOMER WILL RECEIVE A REMINDER NOTICE THAT THEY MUST FOLLOW THE IVD PACKAGE INSERT INSTRUCTIONS FOR USE. FOR CASE #2, SINCE NO FURTHER INFO CAN BE OBTAINED BY THE DISTRIBUTOR FROM THE CUSTOMER, LUMINEX IS ATTEMPTING TO REACH OUT TO THE CUSTOMER ((B)(6)) TO OBTAIN ADDITIONAL INFO.

    Description of Event or Problem · 1

    A US CUSTOMER, (B)(6), REPORTED XTAG RVP FAST IVD KIT, LOT # IK025-0003, HAVING MISSED 1 FLU A POSITIVE SAMPLE RESULT FROM A PT WHO DIED FROM A FLU-RELATED ILLNESS (CASE #1). THE PT WAS A PEDIATRIC PT WITH MULTIPLE HEALTH ISSUES, INCLUDING BONE MARROW PROBLEMS. THE INVESTIGATION INDICATED THAT THE SAMPLE WAS TYPE USED, BAL (BRONCHIAL ALVEOLAR LAVAGE), WAS INCONSISTENT WITH INSTRUCTIONS FOR USE IN THE PACKAGE INSERT. INVESTIGATION ALSO SHOWED THE VOLUME OF SAMPLE EXTRACTED (360 UL) AND METHOD OF EXTRACTION USED (MAGNAPURE 96) WERE ALSO INCONSISTENT WITH THE PACKAGE INSERT INSTRUCTIONS FOR USE. THE INITIAL TESTING OF THE PT SAMPLE WAS BY CULTURE, WHICH WAS POSITIVE FOR H1N1. THE XTAG RVP FAST IVD WAS USED AS A CONFIRMATORY REFLEX TEST FOLLOWING THE POSITIVE CULTURE RESULT AND IT GAVE A NEGATIVE RESULT FOR THE SAMPLE BEING TESTED. RVP FAST KIT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. IN THAT SAME CAROLINAS MEDICAL CENTER REPORT, A SECOND CASE (CASE #2) WAS REPORTED WHERE THE XTAG RVP FAST IVD KIT, LOT # IK025-003, MISSED 1 FLU A POSITIVE PT SAMPLE RESULT FROM A PT WHO HAD DIED SOMETIME IN (B)(6) 2012. THE EVENT WAS NOT REPORTED BY THE CUSTOMER AT THAT TIME AND THE INFO WAS FILED BY (B)(6) TO AN OFF-SITE STORAGE FACILITY. NO INFO ON THE CAUSE OF DEATH WAS PROVIDED. THE NASOPHARYNGEAL SWAB SAMPLE TYPE USED FOR THIS CASE WAS CONSISTENT WITH THE PACKAGE INSERT INSTRUCTIONS FOR USE. THE EXTRACTION METHOD, HOWEVER, IS SUSPECTED TO HAVE BEEN INCONSISTENT WITH THE PACKAGE INSERT BUT WAS NOT CONFIRMED BY THE CUSTOMER. THE CUSTOMER IS NOT WILLING TO SHARE ANY MORE INFO OR DATA ON THIS SECOND CASE. IT IS ALSO SUSPECTED THAT THE CUSTOMER WAS NOT USING THE IVD SOFTWARE PROVIDED WITH THE XTAG RVP FAST KIT BUT THIS COULD NOT BE CONFIRMED. THESE EVENTS WERE COMMUNICATED TO LUMINEX BY ABBOTT MOLECULAR (A DISTRIBUTOR OF THE LUMINEX RVP PRODUCTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XTAG RESPIRATORY VIRAL PANEL FAST XTAG RVP FAST OCC LUMINEX MOLECULAR DIAGNOSTICS, INC. I025C0197 IK025-0003

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Death