BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 10906831 · Received November 25, 2020

    Report

    Report Number
    3006948883-2020-00840
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    November 2, 2020
    Report Date
    October 25, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINTS THAT ALLEGES FALSE NEGATIVE WHEN USING KIT BD VERITOR FOR RAPID DETECTION OF SARS-COV-2 (MN# 256082), BATCH NUMBER 0242768. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE NEGATIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. AN INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. IF YOU HAVE ANY ADDITIONAL QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A POTENTIAL FALSE NEGATIVE RESULT WAS OBTAINED. THERE WAS NO FORM OF REPEAT OR CONFIRMATORY TESTING REPORTED BY THE CUSTOMER. BD HAS ATTEMPTED TO CONTACT THE CUSTOMER MULTIPLE TIMES FOR ADDITIONAL INFORMATION REGARDING THIS EVENT AND THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFORMATION. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT OR ANY REPORT OF PATIENT IMPACT. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A POTENTIAL FALSE NEGATIVE RESULT WAS OBTAINED. THERE WAS NO FORM OF REPEAT OR CONFIRMATORY TESTING REPORTED BY THE CUSTOMER. BD HAS ATTEMPTED TO CONTACT THE CUSTOMER MULTIPLE TIMES FOR ADDITIONAL INFORMATION REGARDING THIS EVENT AND THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFORMATION. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT OR ANY REPORT OF PATIENT IMPACT. EUA (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371581 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 0242768

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown