BEUDAMED
    FDA Adverse Event Death Summary report: N

    XTAG RESPIRATORY VIRAL PANEL

    MDR report key: 2006952 · Received February 28, 2011

    Report

    Report Number
    3002777243-2011-00001
    Event Type
    Death
    Date Received
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    LUMINEX MOLECULAR DIAGNOSTICS, INC.
    Product Code
    OCC
    PMA / PMN Number
    K091667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION CONTINUES. KIT (LOT # IK019C-0021) MET QC RELEASE CRITERIA. NO OUT OF SPECIFICATIONS (OOS) ARE ASSOCIATED WITH THIS KIT LOT. THE THREE EXTRACTED PATIENT SAMPLES WERE RETURNED TO LUMINEX FOR EVALUATION. SAMPLES WERE TESTED WITH AN XTAG RVP KIT OF THE SAME LOT AS WAS USED BY (B)(6). RESULTS OF TESTING AT LUMINEX: KIT LOT (# IK019C-0021) TESTED WITH EXTRACTED SAMPLES SENT BY LAB SHOWED RSVA NEGATIVE IN ONE SAMPLE ((B)(6)), WHILE THE REMAINING SAMPLES RUN WERE 'FAILED' RUNS, SINCE THE INTERNAL CONTROL IN THESE SAMPLES DID NOT PASS, (FURTHER INVESTIGATION ONGOING). POSITIVE CONTROLS IN ALL THREE RUNS PASSED. SEQUENCING OF THE SAMPLES IS BEING PERFORMED. LABELING OF XTAG RVP: INTENDED USE STATES - IT IS RECOMMENDED THAT SPECIMENS FOUND TO BE NEGATIVE FOR INFLUENZA B, RESPIRATORY SYNCYTIAL VIRUS SUBTYPE A AND B, PARAINFLUENZA 1, PARAINFLUENZA 2, PARAINFLUENZA 3 AND ADENOVIRUS, AFTER EXAMINATION USING RVP BE CONFIRMED BY CELL CULTURE. NEGATIVE RESULTS DO NOT PRECLUDE RESPIRATORY VIRUS INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR DIAGNOSIS, TREATMENT OR OTHER MANAGEMENT DECISIONS. ASSAY LIMITATIONS AND WARNINGS STATES, A TRAINED HEALTH CARE PROFESSIONAL SHOULD INTERPRET ASSAY RESULTS IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL SIGNS AND SYMPTOMS, AND THE RESULTS OF OTHER DIAGNOSTIC TESTS. THERE IS A RISK OF FALSE NEGATIVE VALUES RESULTING FROM IMPROPERLY COLLECTED, TRANSPORTED, OR HANDLED SPECIMENS. THERE IS A RISK OF FALSE NEGATIVE VALUES DUE TO THE PRESENCE OF SEQUENCE VARIANTS IN THE VIRAL TARGETS OF THE ASSAY, PROCEDURAL ERRORS, AMPLIFICATION INHIBITORS IN SPECIMENS, OR INADEQUATE NUMBERS OF ORGANISMS FOR AMPLIFICATION. A SPECIMEN YIELDING A NEGATIVE RESULT MAY CONTAIN RESPIRATORY VIRUSES NOT PROBED BY XTAG RVP. CONCLUSION AT THIS TIME: NO REMEDIAL ACTION AT THIS TIME. ON LABEL USE, IS INDICATED THE INTENDED USE ALONG WITH OTHER PRECAUTIONS AND WARNINGS WHICH RECOMMENDS THAT SPECIMENS FOUND TO BE NEGATIVE FOR SOME VIRUSES, INCLUDING RESPIRATORY SYNCYTIAL VIRUS SUBTYPE A (RSVA), BE CONFIRMED BY CELL CULTURE AND NEGATIVE RESULTS DO NOT PRECLUDE RESPIRATORY VIRUS INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR DIAGNOSIS, TREATMENT OR OTHER MANAGEMENT DECISIONS.

    Description of Event or Problem · 1

    US CUSTOMER (B)(6) REPORTED THREE NEGATIVE RESULTS FOR RSVA (RESPIRATORY SYNCYTIAL VIRUS SUBTYPE A) IN EACH OF THREE PATIENT SAMPLES USING THE XTAG RVP (LOT # IK019C-0021). THE LAB INDICATED THAT ADDITIONAL TESTING ON THESE SAMPLES USING ALTERNATIVE METHODS WAS PERFORMED. BASED ON THE ALTERNATIVE TESTING, THE LAB HAS COMMUNICATED THAT RESULTS WERE POSITIVE FOR RSVA. THE LAB COMMUNICATED THAT ONE OF THE THREE PATIENTS DIED SEVERAL DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XTAG RESPIRATORY VIRAL PANEL XTAG RVP OCC LUMINEX MOLECULAR DIAGNOSTICS, INC. I019C011 IK019C-0021

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death REQUESTED BUT UNKNOWN AT THIS TIME.