BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 10759227 · Received October 29, 2020

    Report

    Report Number
    1119779-2020-00842
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    September 12, 2020
    Report Date
    October 18, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED: H.6. FDA PATIENT PROBLEM CODE(S): 1930.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE NEGATIVE OR DISCREPANT RESULTS WHEN USING KIT BD VERITOR FOR RAPID DETECTION OF SARS-COV-2 (MN# (B)(4)), BATCH NUMBER 0198093 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 A FALSE NEGATIVE RESULT WAS OBTAINED. THE PATIENT WAS EXPERIENCING VOMITING, A SAMPLE WAS COLLECTED, AND THE RESULT WAS NEGATIVE. THE PATIENTS CONDITION WORSENED AND THEY WERE TRANSFERRED TO A HOSPITAL. THE PATIENT TESTED POSITIVE FOR COVID VIA PCR A FEW DAYS AFTER ADMISSION. THERE WAS NO FURTHER INFORMATION PROVIDED FROM THE CUSTOMER. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 A FALSE NEGATIVE RESULT WAS OBTAINED. THE PATIENT WAS EXPERIENCING VOMITING, A SAMPLE WAS COLLECTED, AND THE RESULT WAS NEGATIVE. THE PATIENTS CONDITION WORSENED AND THEY WERE TRANSFERRED TO A HOSPITAL. THE PATIENT TESTED POSITIVE FOR COVID VIA PCR A FEW DAYS AFTER ADMISSION. THERE WAS NO FURTHER INFORMATION PROVIDED FROM THE CUSTOMER. (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 FALSE NEGATIVE RESULT WAS OBTAINED. THE PATIENT WAS EXPERIENCING VOMITING, A SAMPLE WAS COLLECTED, AND THE RESULT WAS NEGATIVE. THE PATIENTS CONDITION WORSENED AND THEY WERE TRANSFERRED TO A HOSPITAL. THE PATIENT TESTED POSITIVE FOR COVID VIA PCR A FEW DAYS AFTER ADMISSION. THERE WAS NO FURTHER INFORMATION PROVIDED FROM THE CUSTOMER. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219193 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 0198093

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention