BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 13725899 · Received March 10, 2022

    Report

    Report Number
    3006948883-2022-00075
    Event Type
    Malfunction
    Date Received
    March 10, 2022
    Date of Event
    February 11, 2022
    Report Date
    March 16, 2022
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS MEMO IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE NEGATIVE WHEN USING KIT BD VERITOR FOR RAPID DETECTION OF SARS-COV-2 (MN# 256089), BATCH NUMBER 1121606. 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 WAS CONDUCTED. THE BATCH HISTORY REVIEW DID NOT FIND ANY ISSUE THAT OCCURRED DURING THE MANUFACTURING PROCESS. RETAIN TESTING FOR THE REPORTED LOT WAS PERFORMED AND YIELDED EXPECTED AND INTENDED RESULTS. NO RETURNED SAMPLES WERE RECEIVED. A FURTHER ANALYSIS WAS CONDUCTED ON THE TEST DEVICE, THE EXTRACTION REAGENT, AND THE COLLECTION SWAB. NO ISSUES WERE FOUND LINKING THESE PRODUCTS TO OTHER FALSE NEGATIVE COMPLAINTS. 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.

    Additional Manufacturer Narrative · 0

    THERE IS NO 510(K) FOR THIS DEVICE AS IT IS EUA. EUA (B)(4). 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 WHILE TESTING WITH BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ FALSE NEGATIVE RESULTS WERE OBTAINED. THIS OCCURRED 30 TIMES. CONFIRMATORY TESTING WAS PERFORMED USING ANOTHER BRAND'S TEST. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TAKEN A TEST AT THE SAME TIME IN THE SAME WAY. COMPARED A ROCHE TEST AND BD TEST. ROCHE INDICATES POSITIVE AND BD TEST NEGATIVE . THE COMPLAINT NOW OCCURS AT 2 COMMERCIAL TEST PROVIDERS. THIS CONCERNS A TOTAL OF 30 - 40 TESTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ FALSE NEGATIVE RESULTS WERE OBTAINED. THIS OCCURRED 30 TIMES. CONFIRMATORY TESTING WAS PERFORMED USING ANOTHER BRAND'S TEST. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TAKEN A TEST AT THE SAME TIME IN THE SAME WAY. COMPARED A ROCHE TEST AND BD TEST. ROCHE INDICATES POSITIVE AND BD TEST NEGATIVE . THE COMPLAINT NOW OCCURS AT 2 COMMERCIAL TEST PROVIDERS. THIS CONCERNS A TOTAL OF 30 - 40 TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2360403 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1121606

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown