BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERITOR PRODUCT

    MDR report key: 21910064 · Received April 25, 2025

    Report

    Report Number
    3006948883-2025-00097
    Event Type
    Death
    Date Received
    April 25, 2025
    Date of Event
    March 26, 2025
    Report Date
    April 3, 2025
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    PSZ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2. DATE OF DEATH IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. B3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, D4. UNIQUE IDENTIFIER (UDI) NUMBER: UNKNOWN, H4. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE NEGATIVE WHEN USING UNKNOWN PRODUCT (MATERIAL NUMBER UNKNOWN), BATCH NUMBER UNKNOWN. THE CUSTOMER EXPRESSED CONCERN OVER HIGH FALSE NEGATIVES WITH THE VERITOR FLU A AND B TEST KIT, ALLEGING THIS OCCURRED IN 2009. THEY INDICATED THAT IT COULD HAVE BEEN AS HIGH AS 85 PERCENT WHICH EVEN RESULTED IN A PATIENT DEATH. THE CUSTOMER WAS UNABLE TO CONFIRM A SKU NOR LOT NUMBER FOR THE PRODUCT USED IN 2009. THEY WERE ALSO UNABLE TO CONFIRM ANY DEMOGRAPHIC INFORMATION ABOUT THE PATIENT. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, VISUAL INSPECTION OF RETENTION SAMPLES, AND VISUAL INSPECTION OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING COULD NOT BE PERFORMED AS THERE WAS NO SKU NOR LOT NUMBER PROVIDED. ADDITIONALLY, NO PHOTOS OR SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. COMPLAINT HISTORY REVIEW WAS PERFORMED ON THE VERITOR FLU A AND B PRODUCT FAMILY PER AVAILABLE CUSTOMER INTAKE INFORMATION, AND THE COMPLAINTS FOR THIS PRODUCT FAMILY ARE UNDER CONTROL AND NO ADVERSE TRENDS WERE IDENTIFIED. THERE WERE ALSO NO FALSE NEGATIVE TRENDS NOTED. AT THE TIME OF THE ALLEGATION OCCURRING IN 2009, THE VERITOR FLU A AND B PRODUCT HAD NOT YET BEEN RELEASED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. PER THE IFU, A NEGATIVE TEST IS PRESUMPTIVE AND IT IS RECOMMENDED THAT THESE RESULTS BE CONFIRMED BY VIRAL CULTURE OR AN FDA CLEARED INFLUENZA A AND B MOLECULAR ASSAY. NEGATIVE TEST RESULTS DO NOT PRECLUDE INFLUENZA VIRAL INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR TREATMENT OR OTHER PATIENT MANAGEMENT DECISIONS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING A VERITOR PRODUCT APPROXIMATELY 15 YEARS AGO, ONE (1) PATIENT DEATH WAS ASSOCIATED WITH A FALSE NEGATIVE FLU RESULT AFTER A H1N1 OUTBREAK. IN ADDITION, THERE WAS A HIGH RATE OF FALSE NEGATIVE FLU RESULTS OBTAINED. UPON PCR TESTING, A POSITIVE FLU RESULT WAS OBTAINED. THE CUSTOMER IS UNABLE TO PROVIDE A PRODUCT CATALOG NUMBER, A PRODUCT LOT NUMBER, AN EVENT OCCURRENCE DATE, A DATE OF DEATH, OR MEDICAL DETAILS SURROUNDING THE PATIENT'S ADVERSE EVENT. THE CUSTOMER'S PRODUCT ALLEGATION TIMELINE IS NOT ALIGNED WITH WHEN THE BD VERITOR PRODUCTS WERE RELEASED ON THE MARKET AND NO DATA COULD BE PROVIDED BY THE CUSTOMER TO CORROBORATE THE ALLEGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481393 VERITOR PRODUCT DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS PSZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death