BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B

    MDR report key: 20749941 · Received November 21, 2024

    Report

    Report Number
    3006948883-2024-00085
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    October 23, 2024
    Report Date
    January 31, 2025
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QMN
    UDI-DI
    00382902560883
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION FOR THE PMA/510K IS AS FOLLOWS: G.4. PMA/510(K)#: EUA#: (B)(4). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE AND INVALID RESULT (MULTIPLE LINES PRESENT) WHEN USING BD VERITOR¿ SARS-COV-2 AND FLU A+B ASSAY (MATERIAL#: 256088), BATCH NUMBER 4201749 AND UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED 3 FLU B POSITIVE SAMPLE RESULTS AND WHEN PERFORMING QC TESTING WITH THE FLU A POSITIVE CONTROL SWAB; THE RESULT WAS POSITIVE FOR BOTH FLU A AND B. PER THE CUSTOMER, SAMPLES WERE RECOLLECTED AND PCR WERE PERFORMED AND RESULTS WERE NEGATIVE. THEY ALSO REPEATED THE POSITIVE QC CONTROL SWAB ON A DIFFERENT KIT WITH THE SAME LOT AND GAVE THE EXPECTED RESULT. THEY ARE UNSURE WHICH KIT WAS USED FOR QC CONTROL TESTING. 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 WERE PERFORMED ON THE BATCH NUMBER 4201749. THE RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE FOUND. BHR AND RETAIN SAMPLE TESTING COULD NOT BE PERFORMED ON BATCH NUMBER UNKNOWN. NO SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED FOR 4201749 AND UNKNOWN. A PHOTOGRAPH WAS RETURNED, HOWEVER IT ONLY SHOWED THE KIT LABEL. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR FALSE POSITIVE AND INVALID RESULT (MULTIPLE LINES PRESENT) WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    REPORT 1 OF 3. IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B, ONE (1) FALSE POSITIVE FLU B PATIENT RESULT WAS OBTAINED AND A QC ISSUE OCCURRED DURING TESTING. THE ERRONEOUS RESULT WAS REPORTED. UPON SAMPLE RECOLLECTION AND RETESTING THE PATIENT USING PCR, A NEGATIVE FLU B RESULT WAS OBTAINED. QC WAS REPROCESSED AND PASSED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED. EUA#: (B)(4).

    Description of Event or Problem · 0

    REPORT 1 OF 3: IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B, ONE (1) FALSE POSITIVE FLU B PATIENT RESULT WAS OBTAINED AND A QC ISSUE OCCURRED DURING TESTING. THE ERRONEOUS RESULT WAS REPORTED. UPON SAMPLE RECOLLECTION AND RETESTING THE PATIENT USING PCR, A NEGATIVE FLU B RESULT WAS OBTAINED. QC WAS REPROCESSED AND PASSED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED. EUA# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152790 BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B ANTIGEN DETECTION REAGENT KIT QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 4201749 00382902560883

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown