BEUDAMED
    FDA Adverse Event Death Summary report: N

    XPERT FLU

    MDR report key: 6432850 · Received March 24, 2017

    Report

    Report Number
    3004530258-2017-00001
    Event Type
    Death
    Date Received
    March 24, 2017
    Date of Event
    January 24, 2017
    Report Date
    January 24, 2017
    Manufacturer
    CEPHEID
    Product Code
    OCC
    UDI-DI
    00733294001070
    PMA / PMN Number
    K123191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CEPHEID IS VOLUNTARILY REPORTING THE MDR DUE TO THE DEATH OF THE PATIENT; HOWEVER, THE GXFLU-10A PERFORMANCE MET PACKAGE INSERT CLAIMS. THE [(B)(6) 2017] XPERT FLU A POSITIVE; "20019" H1N1 NOT DETECTED; FLU B NEGATIVE RESULTS INDICATE A WEAK VIRAL LOAD NEAR THE LIMIT OF DETECTION (LOD) BASED ON ENDPOINT AND CYCLE THRESHOLD RESULTS. [(B)(6) 2017 GXFLU-10A RESULT] FLU A=NEG CT=0.0; ENDPT=13; 2009 H1N1=NEG CT=0.0; ENDPT=36; FLU B=NEG CT=0.0; ENDPT=0; SPC=PASS CT=28.9; ENDPT=224. [(B)(6) 2017 GXFLU-10A RESULT] FLU A=POS CT=37; ENDPT=23; 2009 H1N1=NEG CT=0.0; ENDPT=19; FLU B=NEG CT=0.0; ENDPT=0; SPC=PASS CT=27.6; ENDPT=374. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    INITIAL XPERT FLU A TEST RESULT WAS NEGATIVE AND REPORTED TO THE MD. CUSTOMER SENDS ALL FLU SAMPLES TO A RESEARCH TEAM AND TESTED WITH BIOFIRE RESPIRATORY PANEL TEST WHICH YIELDED A FLU A POSITIVE. ORIGINAL REPORT TO THE MD AMENDED TO FLU A POSITIVE. TRANSPORT MEDIA USED WAS NOT INDICATED FOR USE WITH THIS TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215171 XPERT FLU GXFLU-10A OCC CEPHEID XPERT FLU 1000038851 00733294001070

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death