BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 18977840 · Received March 26, 2024

    Report

    Report Number
    3006948883-2024-00040
    Event Type
    Malfunction
    Date Received
    March 26, 2024
    Date of Event
    August 31, 2023
    Report Date
    July 2, 2024
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    UDI-DI
    00382902560821
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 05-APRI-2024. INVESTIGATION SUMMARY : THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVES WHEN USING RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL#: 256082), BATCH NUMBER 3251389. THE CUSTOMER REPORTED THAT THEY WERE RECEIVING FALSE POSITIVE RESULTS WITH PATIENT SAMPLES USING THE VERITOR ANALYZER. 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 PROVIDED. THE RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE FOUND. A PHOTOGRAPH WAS RECEIVED, BUT IT ONLY SHOWS BATCH NUMBER IDENTIFICATION OF THE KIT. RETURN SAMPLES WERE RECEIVED ON THE BATCH NUMBER PROVIDED AND THE RESULTS WERE ACCEPTABLE. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR FALSE POSITIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    (B)(4). H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD RAPID DETECTION OF SARS-COV-2 VERITOR¿, THERE WERE AN UNSPECIFIED NUMBER OF FALSE POSITIVE RESULTS ON A REGULAR BASIS FROM SEPTEMBER 2023 THROUGH JANUARY 2024. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD RAPID DETECTION OF SARS-COV-2 VERITOR¿, THERE WERE AN UNSPECIFIED NUMBER OF FALSE POSITIVE RESULTS ON A REGULAR BASIS FROM (B)(6) 2023 THROUGH (B)(6) 2024. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460399 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 3251389 00382902560821

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown