BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOFIA INFLUENZA A+B

    MDR report key: 5003407 · Received August 12, 2015

    Report

    Report Number
    2024674-2015-00001
    Event Type
    Death
    Date Received
    August 12, 2015
    Date of Event
    December 27, 2014
    Report Date
    October 9, 2015
    Manufacturer
    QUIDEL CORP.
    Product Code
    GNX
    PMA / PMN Number
    K131606
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE LOT NUMBER NOT BEING AVAILABLE, MANUFACTURER WAS UNABLE TO PERFORM AN INVESTIGATION. MANUFACTURER MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE COMPLAINANT. PHONE CALLS AND EMAILS WERE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE TO REQUEST ADDITIONAL INFORMATION, INCLUDING PHONE CALLS AND EMAILS. CUSTOMER WAS UNRESPONSIVE. IN RESPONSE TO A REQUEST FROM FDA, FURTHER ATTEMPTS WERE MADE, AND THE SALES MANAGER WAS SENT TO THE SITE TO OBTAIN INFORMATION AND PROVIDE SD CARDS SO THAT THE ANALYZER DATA COULD BE DOWNLOADED AND FORWARDED TO QUIDEL FOR REVIEW. THE ASSAY LOT NUMBER AND ANALYZER SERIAL NUMBER WERE OBTAINED. IN-HOUSE TESTING WAS PERFORMED ON RETAINS FROM THE LOT IN QUESTION. FIVE CASSETTES EACH WERE TESTED WITH NEGATIVE STANDARD, FRESH, AND IN M4, M5, M6 AND UTM VIRAL TRANSPORT MEDIA. ALL RESULTS PASSED, AND THE (B)(6) COULD NOT BE REPLICATED. THE ANALYZER DATA WAS REVIEWED. THE EARLIEST PATIENT RESULT STORED IN THE EXPORT LOG WAS DATED (B)(6) 2015 (EVENT DATE WAS (B)(6) 2014). THE ANALYZER HOLDS A MAXIMUM OF 500 PATIENT RESULTS. HOWEVER, THE CALIBRATION RESULTS ((B)(6) 2014 AND (B)(6) 2015) AND THE QC RESULTS ((B)(6) 2014) THAT BRACKET THE (B)(6) 2014 EVENT DATE SHOWED THE ANALYZER PERFORMING AS EXPECTED. THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED AND NO ISSUES WERE NOTED THAT WOULD CONTRIBUTE TO A (B)(6) RESULT. COMPLAINT DATA FOR THIS LOT AND THE LAST YEAR WERE REVIEWED - NO TREND WAS IDENTIFIED.

    Description of Event or Problem · 1

    (B)(6). TEST WAS CONFIRMED AS (B)(6) BY PCR AT A STATE LABORATORY. PT WAS TREATED AND 2 DAYS LATER WAS ADMITTED TO THE HOSPITAL AS BEING SEPTIC.

    Description of Event or Problem · 1

    A (B)(6) WAS OBTAINED ON (B)(6) 2014, AND LATER CONFIRMED AS (B)(6) BY PCR (ASKU - ASKED BUT UNAVAILABLE). PATIENT WAS PRESCRIBED TAMIFLU AND SENT HOME. PATIENT RETURNED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2014 AND WAS ADMITTED TO A CHILDREN'S SPECIALTY HOSPITAL. BLOOD CULTURES WERE DRAWN AND WERE REPORTED AS (B)(6) ON (B)(6) 2014. PATIENT DIED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529275 SOFIA INFLUENZA A+B SOFIA INFLUENZA A+B GNX QUIDEL CORP. NA 108166

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Death| H