BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 12310605 · Received August 11, 2021

    Report

    Report Number
    1119779-2021-01357
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    August 5, 2021
    Report Date
    September 13, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 1181838. D.4. MEDICAL DEVICE EXPIRATION DATE: 6/2/2022. H.4. DEVICE MANUFACTURE DATE: 6/30/2021. H.6. INVESTIGATION: THIS IS TO SUMMARIZE THE INVESTIGATION RESULTS FOR CUSTOMER COMPLAINTS ALLEGING FALSE POSITIVE OR DISCREPANT RESULTS WHEN USING THE KIT BD VERITOR FOR RAPID DETECTION OF SARS-COV-2 (REF# (B)(4).BATCH #: 1181838). 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). THE BATCH HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE NOTED. FUNCTIONAL ANALYSIS OF RETENTION MATERIALS MET ACCEPTANCE CRITERIA. NO RETURNS WERE RECEIVED TO INVESTIGATE. BASED ON THE PHOTOS PROVIDED BY THE CUSTOMER, THE ISSUE WAS CONFIRMED. HOWEVER, QUALITY WAS UNABLE TO DUPLICATE THE CUSTOMERS REPORTED FAILURE MODE. COMPLAINT TRENDING REVIEW REVEALS A TREND IN CUSTOMER COMPLAINTS RELATED TO FALSE POSITIVE RESULTS, WHEN USING BD SARS-COV-2 REAGENTS FOR BD VERITOR¿ SYSTEM, CAPA#1878253 HAS BEEN CREATED TO INVESTIGATE ROOT CAUSE AND DETERMINE APPROPRIATE CORRECTIVE AND PREVENTATIVE ACTIONS. BD POINT OF CARE WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH FALSE POSITIVE OR DISCREPANT RESULTS WHEN USING THE KIT BD VERITOR FOR RAPID DETECTION OF SARS-COV-2. THERE WAS NO CORRECTIVE ACTION TAKEN AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. A REPEAT TEST WAS PERFORMED USING PCR AND THE RESULT WAS NEGATIVE. 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: INCIDENT OCCURRED AT 7.07PM AT 5 JOO KOON (ONE OF THE NTUC WAREHOUSES) ON (B)(6) 2021. NASAL SWAB WAS OBTAINED. SWAB WAS MIXED IN THE BUFFER TUBE FOR 15 SECONDS. 3 FULL DROPS WERE DISPENSED ON CARTRIDGE AND WAS INCUBATED FOR 15 MINUTES IN A BENTO BOX. ANAZLYER NOW MODE WAS USED IN THE SETTING. ANALYZER READ AS COV2+, 1 CONTROL LINE PRESENT UPON VISUAL CHECK. PHOTOS ATTACHED WERE TAKEN BY LAB PERSONNEL. PATIENT WAS ASKED TO DO PCR BY PARKWAY, RESULT WAS OUT ON (B)(6) 2021 - PCR NEGATIVE RESULT. HENCE, REPORTING COMPLAINT AS FALSE POSITIVE.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ADDRESS: (B)(6). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 A FALSE POSITIVE RESULT WAS OBTAINED. A REPEAT TEST WAS PERFORMED USING PCR AND THE RESULT WAS NEGATIVE. 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: INCIDENT OCCURRED AT 7.07PM AT (B)(6) ON (B)(6) 2021. NASAL SWAB WAS OBTAINED. SWAB WAS MIXED IN THE BUFFER TUBE FOR 15 SECONDS. 3 FULL DROPS WERE DISPENSED ON CARTRIDGE AND WAS INCUBATED FOR 15 MINUTES IN A BENTO BOX. ANAZLYER NOW MODE WAS USED IN THE SETTING. ANALYZER READ AS COV2+, 1 CONTROL LINE PRESENT UPON VISUAL CHECK. PHOTOS WERE TAKEN BY LAB PERSONNEL. PATIENT WAS ASKED TO DO PCR BY PARKWAY, RESULT WAS OUT ON (B)(6) 2021 - PCR NEGATIVE RESULT. HENCE, REPORTING COMPLAINT AS FALSE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207247 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 1181838

    Patients

    Seq Age Sex Outcome Treatment
    1