BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY

    MDR report key: 10666749 · Received October 12, 2020

    Report

    Report Number
    3006948883-2020-00546
    Event Type
    Malfunction
    Date Received
    October 12, 2020
    Date of Event
    September 14, 2020
    Report Date
    March 26, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EUA#: (B)(4). INVESTIGATION SUMMARY: BD HAS RECEIVED SEVERAL CUSTOMER COMPLAINTS FOR FALSE POSITIVE RESULTS, WHEN USING BD SARS-COV-2 REAGENTS FOR BD VERITOR¿ SYSTEM. THE CURRENT INVESTIGATION CONCERNS MULTIPLE LOTS OF BD SARS-COV-2 REAGENTS FOR BD VERITOR¿ SYSTEM. BD TAKES A SYSTEMATIC APPROACH TO INVESTIGATING FALSE POSITIVE COMPLAINTS THAT ARE RECEIVED. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. RETAIN SAMPLES WERE TESTED FOR BATCH #: 0213905. THE DEFECT COULD NOT BE REPLICATED AND THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0213905. THE INVESTIGATION DID NOT FIND A ROOT CAUSE FOR THE FALSE POSITIVE RESULTS THAT WERE OBSERVED. IT IS RECOMMENDED THAT EACH CUSTOMER REVIEW THEIR WORKFLOW CAREFULLY TO ENSURE THAT THE PACKAGE INSERT IS BEING FOLLOWED AS WRITTEN. THE ROOT CAUSE IS UNDER INVESTIGATION AND WILL BE DOCUMENTED IN OUR QUALITY SYSTEM. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA#1878253) IS ALREADY INITIATED TO INVESTIGATE THE ROOT CAUSE AND SOME MITIGATION ACTIONS ARE ALREADY BEING ADDRESSED.

    Additional Manufacturer Narrative · 0

    THIS REPORT INCORRECTLY CAPTURED 3 FALSE POSITIVES. THIS MDR IS ONLY FOR THE ONE FALSE POSITIVE ON 9/15. (B)(4) CAPTURED THE TWO OTHER FALSE POSITIVES ON 9/17 AND (B)(4) CAPTURED THE FALSE NEGATIVE. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.5. DESCRIBE EVENT OR PROBLEM: "IT WAS REPORTED WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY 1 FALSE POSITIVE RESULTS WERE OBTAINED BY THE CUSTOMER. A REPEAT TEST WAS PERFORMED USING PCR AND THE RESULT WAS NEGATIVE. PATIENT WAS ISOLATED INITIALLY, THERE WAS NO PATIENT IMPACT OTHERWISE NOTED. EUA#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY 1 FALSE POSITIVE RESULTS WERE OBTAINED BY THE CUSTOMER. A REPEAT TEST WAS PERFORMED USING PCR AND THE RESULT WAS NEGATIVE. PATIENT WAS ISOLATED INITIALLY, THERE WAS NO PATIENT IMPACT OTHERWISE NOTED. EUA#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY 1 FALSE POSITIVE RESULTS WERE OBTAINED BY THE CUSTOMER. A REPEAT TEST WAS PERFORMED USING PCR AND THE RESULT WAS NEGATIVE. PATIENT WAS ISOLATED INITIALLY, THERE WAS NO PATIENT IMPACT OTHERWISE NOTED. EUA#: (B)(4).

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY 3 FALSE POSITIVE RESULTS WERE OBTAINED BY THE CUSTOMER. REPEAT TESTS WERE PERFORMED USING PCR AND THE RESULTS WERE NEGATIVE. PATIENTS WERE ISOLATED INITIALLY, THERE WAS NO PATIENT IMPACT OTHERWISE NOTED. EUA#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131854 BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 0213905

    Patients

    Seq Age Sex Outcome Treatment
    1 Other