BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 13285522 · Received January 18, 2022

    Report

    Report Number
    1119779-2021-02175
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Date of Event
    December 24, 2021
    Report Date
    March 17, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED LOT# 0183123 WAS NOT FOUND FOR THE REPORTED CATALOG# 256082. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE NEGATIVE WHEN USING RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082), INVALID BATCH NUMBER 0183123. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE NEGATIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, VISUAL INSPECTION OF RETENTION SAMPLES, AND VISUAL INSPECTION OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION COULD NOT BE PERFORMED AS AN INVALID BATCH NUMBER 0183123 WAS PROVIDED. THE CUSTOMER INITIALLY PROVIDED AN INCORRECT EXPIRATION DATE OF 12/22/21, AND REPORTED THAT THE KIT HAD AN EXPIRATION DATE OF 12/22/20, WHICH IS MORE THAN A YEAR FROM DATE OF EXPIRY. THE COMPLAINT IS UNABLE TO BE CONFIRMED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2, THE BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ PRODUCED A FALSE NEGATIVE RESULT. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS ALSO NO REPORT OF ADVERSE PATIENT IMPACT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS FNS WITH 256082, LOT #0183123." "TOWARD THE END OF THE CALL, CUSTOMER NOTED THAT THE EXPIRATION DATE (12/22/21) HE INITIALLY GAVE ME WAS INCORRECT, AND REPORTED THAT THE KIT HAD AN EXPIRATION DATE OF 12/22/20, WHICH IS MORE THAN A YEAR FROM DATE OF EXPIRY." "1. HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? 1 - 12/22 THEN 12/24, AND 12/26. 2. WHAT IS THE COLLECTION DATE AND TIME FOR EACH DISCREPANT SAMPLE? 12/22 - 6PM , 12/24- 6 PM, AND 12/26- 6 PM. 3. WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC.)? 4. WAS THE PATIENT(S) SYMPTOMATIC WHEN TESTED ON THE VERITOR PLUS ANALYZER? YES. 5. HOW THE TEST IS BEING USED ¿ SYMPTOMATIC PATIENTS. 6. ASYMPTOMATIC PATIENTS OR DR. RECOMMENDED TESTING? SYMPTOMATIC PATIENTS BEING TESTED 7. DID YOU VISUALLY INTERPRET THE RESULT OR DID YOU INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? INSERTED INTO ANALYZER. 8. WERE THE KIT QC SWABS TESTED AND IF SO, DID THEY PASS? YES, AND THEY PASSES. 9. WAS THERE PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? NO. 10. IF YES, WERE RESULTS REPORTED TO A MEDICAL DOCTOR? 11. IF YES, DID THE PATIENT RECEIVE TREATMENT? NO. 12. IF YES, ANY ADVERSE EFFECT ON THE PATIENT? NO. 13. HOW WAS THE SPECIMEN COLLECTED? DID IT FOLLOW THE DUAL-NARES COLLECTION METHOD DESCRIBED IN THE QRI? YES. 14. WHAT TYPE OF SWAB WAS USED TO COLLECT THE SPECIMEN? 25-15061PF100 PURITAN STERILE FOAM TIP APPLICATOR. TIPS WERE INADVERTENTLY THROWN OUT BY ANOTHER EMPLOYEE... 15. WAS ANY TRANSPORT MEDIA USED? NO. 16. HOW LONG AFTER SPECIMEN COLLECTION WAS THE SPECIMEN PROCESSED IN THE EXTRACTION REAGENT? IMMEDIATELY. 17. HOW LONG WAS THE SWAB PLACE INSIDE THE EXTRACTION REAGENT? 30 SECONDS OF SWISHING. 18. HOW LONG AFTER PROCESSING IN THE EXTRACTION REAGENT WAS THE SPECIMEN RUN ON THE TEST CARTRIDGE? IMMEDIATELY. 19. HOW MANY DROPS WERE ADDED TO THE SAMPLE WELL ON THE TEST DEVICE? 3 DROPS. 20. INCUBATION TIME: HOW LONG WAS SAMPLE RUN ON THE CARTRIDGE BEFORE READING? 15-MINUTES. 21. WAS WALK-AWAY MODE USED OR ANALYZE NOW MODE? ANALYZE NOW MODE. 22. TEMPERATURE: CLARIFY THE ENVIRONMENT TEMPERATURE AND TIME OF TEST. WAS TESTING PERFORMED INDOORS OR OUTDOORS (NOT COLLECTION)? ROOM TEMP AND INDOORS. 23. HOW MANY TOTAL SAMPLES HAVE YOU PROCESSED? 3 TOTAL SAMPLES".

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2, THE BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ PRODUCED A FALSE NEGATIVE RESULT. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS ALSO NO REPORT OF ADVERSE PATIENT IMPACT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS FNS WITH 256082, LOT #0183123." "TOWARD THE END OF THE CALL, CUSTOMER NOTED THAT THE EXPIRATION DATE (12/22/21) HE INITIALLY GAVE ME WAS INCORRECT, AND REPORTED THAT THE KIT HAD AN EXPIRATION DATE OF 12/22/20, WHICH IS MORE THAN A YEAR FROM DATE OF EXPIRY." "1. HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? 1 - 12/22 THEN 12/24, AND 12/26. 2. WHAT IS THE COLLECTION DATE AND TIME FOR EACH DISCREPANT SAMPLE? 12/22 - 6PM , 12/24- 6 PM, AND 12/26- 6 PM. 3. WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC.)? 4. WAS THE PATIENT(S) SYMPTOMATIC WHEN TESTED ON THE VERITOR PLUS ANALYZER? YES. 5. HOW THE TEST IS BEING USED ¿ SYMPTOMATIC PATIENTS. 6. ASYMPTOMATIC PATIENTS OR DR. RECOMMENDED TESTING? SYMPTOMATIC PATIENTS BEING TESTED . 7. DID YOU VISUALLY INTERPRET THE RESULT OR DID YOU INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? INSERTED INTO ANALYZER. 8. WERE THE KIT QC SWABS TESTED AND IF SO, DID THEY PASS? YES, AND THEY PASSES. 9. WAS THERE PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? NO. 10. IF YES, WERE RESULTS REPORTED TO A MEDICAL DOCTOR? 11. IF YES, DID THE PATIENT RECEIVE TREATMENT? NO. 12. IF YES, ANY ADVERSE EFFECT ON THE PATIENT? NO. 13. HOW WAS THE SPECIMEN COLLECTED? DID IT FOLLOW THE DUAL-NARES COLLECTION METHOD DESCRIBED IN THE QRI? YES. 14. WHAT TYPE OF SWAB WAS USED TO COLLECT THE SPECIMEN? 25-15061PF100 PURITAN STERILE FOAM TIP APPLICATOR. TIPS WERE INADVERTENTLY THROWN OUT BY ANOTHER EMPLOYEE... 15. WAS ANY TRANSPORT MEDIA USED? NO. 16. HOW LONG AFTER SPECIMEN COLLECTION WAS THE SPECIMEN PROCESSED IN THE EXTRACTION REAGENT? IMMEDIATELY. 17. HOW LONG WAS THE SWAB PLACE INSIDE THE EXTRACTION REAGENT? 30 SECONDS OF SWISHING. 18. HOW LONG AFTER PROCESSING IN THE EXTRACTION REAGENT WAS THE SPECIMEN RUN ON THE TEST CARTRIDGE? IMMEDIATELY. 19. HOW MANY DROPS WERE ADDED TO THE SAMPLE WELL ON THE TEST DEVICE? 3 DROPS. 20. INCUBATION TIME: HOW LONG WAS SAMPLE RUN ON THE CARTRIDGE BEFORE READING? 15-MINUTES. 21. WAS WALK-AWAY MODE USED OR ANALYZE NOW MODE? ANALYZE NOW MODE. 22. TEMPERATURE: CLARIFY THE ENVIRONMENT TEMPERATURE AND TIME OF TEST. WAS TESTING PERFORMED INDOORS OR OUTDOORS (NOT COLLECTION)? ROOM TEMP AND INDOORS. 23. HOW MANY TOTAL SAMPLES HAVE YOU PROCESSED? 3 TOTAL SAMPLES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036301 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown