BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 12291417 · Received August 6, 2021

    Report

    Report Number
    3006948883-2021-00873
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 7, 2021
    Report Date
    October 20, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING THE COMPLAINTS THAT ALLEGES FALSE NEGATIVE OR DISCREPANT RESULTS WHEN USING KIT BD VERITOR FOR RAPID DETECTION OF SARS-COV-2 CE (MATERIAL # 256089), BATCH NUMBER 1020841. 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. INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBERS PROVIDED. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THE COMPLAINT SAMPLE WAS RETURNED TO BD AS NOTED IN TRACKING NUMBER DHL (B)(4). THE RETURNED PRODUCT WAS RECEIVED ON 8/4/2021. THE PRODUCT EXPIRED ON 6/22/2021. BD MAKES NO CLAIMS ON EXPIRED PRODUCTS AND STABILITY STUDIES HAVE SHOWN THE USE OF EXPIRED MATERIALS MAY AFFECT THE SENSITIVITY OF THE ASSAY. THEREFORE, RETURNED MATERIALS PAST THE EXPIRY WILL NOT BE TESTED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 2 FALSE NEGATIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING PCR AND THE RESULTS WERE POSITIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PARKWAY HAS RAISED CONCERN ABOUT HAVING 02 FALSE NEGATIVE OUT OF 13 SAMPLES TESTED ON THE SAME DAY.".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 2 FALSE NEGATIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING PCR AND THE RESULTS WERE POSITIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PARKWAY HAS RAISED CONCERN ABOUT HAVING 02 FALSE NEGATIVE OUT OF 13 SAMPLES TESTED ON THE SAME DAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184932 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1020841

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown