BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 13691036 · Received March 8, 2022

    Report

    Report Number
    3006948883-2022-00070
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 9, 2022
    Report Date
    March 3, 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

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: THIS MEMO 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# (B)(4), BATCH NUMBER UNKNOWN. 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. ALTHOUGH THE BATCH NUMBER WAS NOT IDENTIFIED, AN INVESTIGATION WAS CONDUCTED ON TWO DIFFERENT LOTS, 1121606 AND 1128468 WHICH WERE THE TWO LOTS MOST LIKELY ASSOCIATED WITH THIS COMPLAINT. 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 DEVICES, THE EXTRACTION REAGENTS, AND THE COLLECTION SWABS. 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. IF YOU HAVE ANY ADDITIONAL QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES. EUA(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 USING BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ THE CUSTOMER RECEIVED FALSE NEGATIVE RESULTS. SUBSEQUENT NON-BD ANTIGEN TESTS AND PCR TESTS PRODUCED POSITIVE RESULTS. THIS EVENT OCCURRED 15 TIMES. THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TWO AND A HALF WEEKS AGO (B)(6) I WAS CALLED BY AN END USER ((B)(6)) WHO HAD 3 CASES IN WHICH THE BD VERITOR SARS-COV-2 TEST SHOWED A NEGATIVE RESULT WHILE ANOTHER ANTIGEN TEST SHOWED A POSITIVE RESULT." ; ". ALSO IN THE MEANWHILE HE DID HAVE 15 OF THESE CASES NOW. " ; "IN SOME CASES A PCR TEST WAS PERFORMED TO CONFIRM THE POSITIVE RESULT FROM THE SECONDARY AG-TEST. IN MOST CASES JUST A SECONDARY AG-TEST WAS COLLECTED WHICH HAD A POSITIVE RESULTS WHEN THE BD VERITOR SHOWED A NEGATIVE RESULT." EUA(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482767 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown