BD VERITOR¿ SARS-COV-2 AND FLU A+B
Report
- Report Number
- 3006948883-2021-00957
- Event Type
- Malfunction
- Date Received
- October 6, 2021
- Date of Event
- September 7, 2021
- Report Date
- November 5, 2021
- Manufacturer
- BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
- Product Code
- QMN
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 9/16/2021. H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT BD VERITOR¿ SARS-COV-2 AND FLU A+B ASSAY (SELECT: MATERIAL # 256088), BATCH NUMBER 1189936. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE REPORTED WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.
CORRECTION: THE FOLLOWING FIELDS WERE ENTERED INCORRECTLY AND HAVE BEEN UPDATED: D.2. COMMON DEVICE NAME: NOT CLASSIFIED. D.2. MEDICAL DEVICE TYPE: QMN.
IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 ON THE BD VERITOR¿ SARS-COV-2 AND FLU A+B, A FALSE POSITIVE RESULT FOR FLU A+ WAS PRODUCED. PCR TESTING CONFIRMED THAT THE TEST WAS NEGATIVE. CLINICIANS WERE MADE AWARE OF THE RESULTS, AND THE SYMPTOMATIC PATIENT RECEIVED APPROPRIATE TREATMENT. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING A FALSE POSITIVE WITH 256088." "RECEIVED AN EMAIL FROM CUSTOMER STATING THAT THEY RAN THREE BACK-TO-BACK SAMPLES WHICH WERE FLU A+ WITH 256088. CUSTOMER WAS CONCERNED WITH THESE RESULTS AND DECIDED TO RUN ON 256082 AND 256045 TO CHECK. OUT OF THOSE THREE FLU A+ SAMPLES, ONLY ONE SAMPLE RESULTED AS SARS-COV-2 + AND FLU A- WHEN TESTED SEPARATELY WITH 256082 AND 256045, RESPECTIVELY." 1. HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? 1 2. WHAT IS THE COLLECTION DATE AND TIME FOR EACH DISCREPANT SAMPLE? (B)(4) 221 @ 1715-1815 3. WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC.)? BD VERITOR STAND ALONE FLUA/B AND STAND ALONE COVID, SHL PCR TEST. 4. WAS THE PATIENT(S) SYMPTOMATIC WHEN TESTED ON THE VERITOR PLUS ANALYZER? YES. 5. HOW THE TEST IS BEING USED ¿ AS SPECIFIED IN THE DIRECTIONS PROVIDED WITH THE TEST KITS. 6. ASYMPTOMATIC PATIENTS OR DR. RECOMMENDED TESTING? SEE NUMBER 4. 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; YES. 9. WAS THERE PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? NO. 10. IF YES, WERE RESULTS REPORTED TO A MEDICAL DOCTOR? ORDERING PROVIDERS ARE AWARE. 11. IF YES, DID THE PATIENT RECEIVE TREATMENT? PATIENTS RECEIVED APPROPRIATE TREATMENT. 12. IF YES, ANY ADVERSE EFFECT ON THE PATIENT? SEE NUMBER 9. 13. HOW WAS THE SPECIMEN COLLECTED? DID IT FOLLOW THE DUAL-NARES COLLECTION METHOD DESCRIBED IN THE QRI? YES; SPECIMEN COLLECTION INSTRUCTIONS WERE UTILIZED. 14. WHAT TYPE OF SWAB WAS USED TO COLLECT THE SPECIMEN? THE SWABS INCLUDED IN THE TESTING KIT. 15. WAS ANY TRANSPORT MEDIA USED? THE TRANSPORT MEDIA INCLUDED IN THE TESTING KIT. 16. HOW LONG AFTER SPECIMEN COLLECTION WAS THE SPECIMEN PROCESSED IN THE EXTRACTION REAGENT? SPECIMENS WERE PROCESSED WITHIN 90 SECONDS OF COLLECTION. 17. HOW LONG WAS THE SWAB PLACE INSIDE THE EXTRACTION REAGENT? 15-30 SECONDS. 18. HOW LONG AFTER PROCESSING IN THE EXTRACTION REAGENT WAS THE SPECIMEN RUN ON THE TEST CARTRIDGE? RIGHT AWAY. 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. 22. TEMPERATURE: CLARIFY THE ENVIRONMENT TEMPERATURE AND TIME OF TEST. WAS TESTING PERFORMED INDOORS OR OUTDOORS (NOT COLLECTION)? INDOORS AT APPX 70 DEGREES FARENHEIT.
IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 ON THE BD VERITOR¿ SARS-COV-2 AND FLU A+B, A FALSE POSITIVE RESULT FOR FLU A+ WAS PRODUCED. PCR TESTING CONFIRMED THAT THE TEST WAS NEGATIVE. CLINICIANS WERE MADE AWARE OF THE RESULTS, AND THE SYMPTOMATIC PATIENT RECEIVED APPROPRIATE TREATMENT. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING A FALSE POSITIVE WITH 256088." "RECEIVED AN EMAIL FROM CUSTOMER STATING THAT THEY RAN THREE BACK-TO-BACK SAMPLES WHICH WERE FLU A+ WITH 256088. CUSTOMER WAS CONCERNED WITH THESE RESULTS AND DECIDED TO RUN ON 256082 AND 256045 TO CHECK. OUT OF THOSE THREE FLU A+ SAMPLES, ONLY ONE SAMPLE RESULTED AS SARS-COV-2 + AND FLU A- WHEN TESTED SEPARATELY WITH 256082 AND 256045, RESPECTIVELY." 1. HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? 1. 2. WHAT IS THE COLLECTION DATE AND TIME FOR EACH DISCREPANT SAMPLE? 9/8/21 @ 1715-1815. 3. WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC.)? BD VERITOR STAND ALONE FLUA/B AND STAND ALONE COVID, SHL PCR TEST. 4. WAS THE PATIENT(S) SYMPTOMATIC WHEN TESTED ON THE VERITOR PLUS ANALYZER? YES. 5. HOW THE TEST IS BEING USED ¿ AS SPECIFIED IN THE DIRECTIONS PROVIDED WITH THE TEST KITS. 6. ASYMPTOMATIC PATIENTS OR DR. RECOMMENDED TESTING? 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; YES. 9. WAS THERE PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? NO. 10. IF YES, WERE RESULTS REPORTED TO A MEDICAL DOCTOR? ORDERING PROVIDERS ARE AWARE. 11. IF YES, DID THE PATIENT RECEIVE TREATMENT? PATIENTS RECEIVED APPROPRIATE TREATMENT. 12. IF YES, ANY ADVERSE EFFECT ON THE PATIENT? 13. HOW WAS THE SPECIMEN COLLECTED? DID IT FOLLOW THE DUAL-NARES COLLECTION METHOD DESCRIBED IN THE QRI? YES; SPECIMEN COLLECTION INSTRUCTIONS WERE UTILIZED. 14. WHAT TYPE OF SWAB WAS USED TO COLLECT THE SPECIMEN? THE SWABS INCLUDED IN THE TESTING KIT. 15. WAS ANY TRANSPORT MEDIA USED? THE TRANSPORT MEDIA INCLUDED IN THE TESTING KIT. 16. HOW LONG AFTER SPECIMEN COLLECTION WAS THE SPECIMEN PROCESSED IN THE EXTRACTION REAGENT? SPECIMENS WERE PROCESSED WITHIN 90 SECONDS OF COLLECTION. 17. HOW LONG WAS THE SWAB PLACE INSIDE THE EXTRACTION REAGENT? 15-30 SECONDS. 18. HOW LONG AFTER PROCESSING IN THE EXTRACTION REAGENT WAS THE SPECIMEN RUN ON THE TEST CARTRIDGE? RIGHT AWAY. 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. 22. TEMPERATURE: CLARIFY THE ENVIRONMENT TEMPERATURE AND TIME OF TEST. WAS TESTING PERFORMED INDOORS OR OUTDOORS (NOT COLLECTION)? INDOORS AT APPX 70 DEGREES FARENHEIT.
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.
IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 ON THE BD VERITOR¿ SARS-COV-2 AND FLU A+B, A FALSE POSITIVE RESULT FOR FLU A+ WAS PRODUCED. PCR TESTING CONFIRMED THAT THE TEST WAS NEGATIVE. CLINICIANS WERE MADE AWARE OF THE RESULTS, AND THE SYMPTOMATIC PATIENT RECEIVED APPROPRIATE TREATMENT. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING A FALSE POSITIVE WITH 256088." "RECEIVED AN EMAIL FROM CUSTOMER STATING THAT THEY RAN THREE BACK-TO-BACK SAMPLES WHICH WERE FLU A+ WITH 256088. CUSTOMER WAS CONCERNED WITH THESE RESULTS AND DECIDED TO RUN ON 256082 AND 256045 TO CHECK. OUT OF THOSE THREE FLU A+ SAMPLES, ONLY ONE SAMPLE RESULTED AS SARS-COV-2 + AND FLU A- WHEN TESTED SEPARATELY WITH 256082 AND 256045, RESPECTIVELY." HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? 1 . WHAT IS THE COLLECTION DATE AND TIME FOR EACH DISCREPANT SAMPLE? (B)(6) 2021 @ 1715-1815 WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC.)? BD VERITOR STAND ALONE FLUA/B AND STAND ALONE COVID, SHL PCR TEST . WAS THE PATIENT(S) SYMPTOMATIC WHEN TESTED ON THE VERITOR PLUS ANALYZER? YES. HOW THE TEST IS BEING USED ¿ AS SPECIFIED IN THE DIRECTIONS PROVIDED WITH THE TEST KITS ASYMPTOMATIC PATIENTS OR DR. RECOMMENDED TESTING? SEE NUMBER 4. DID YOU VISUALLY INTERPRET THE RESULT OR DID YOU INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? INSERTED INTO ANALYZER. WERE THE KIT QC SWABS TESTED AND IF SO, DID THEY PASS? YES; YES. WAS THERE PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? NO. IF YES, WERE RESULTS REPORTED TO A MEDICAL DOCTOR? ORDERING PROVIDERS ARE AWARE. IF YES, DID THE PATIENT RECEIVE TREATMENT? PATIENTS RECEIVED APPROPRIATE TREATMENT. IF YES, ANY ADVERSE EFFECT ON THE PATIENT? SEE NUMBER 9. HOW WAS THE SPECIMEN COLLECTED? DID IT FOLLOW THE DUAL-NARES COLLECTION METHOD DESCRIBED IN THE QRI? YES; SPECIMEN COLLECTION INSTRUCTIONS WERE UTILIZED. WHAT TYPE OF SWAB WAS USED TO COLLECT THE SPECIMEN? THE SWABS INCLUDED IN THE TESTING KIT. WAS ANY TRANSPORT MEDIA USED? THE TRANSPORT MEDIA INCLUDED IN THE TESTING KIT. HOW LONG AFTER SPECIMEN COLLECTION WAS THE SPECIMEN PROCESSED IN THE EXTRACTION REAGENT? SPECIMENS WERE PROCESSED WITHIN 90 SECONDS OF COLLECTION. HOW LONG WAS THE SWAB PLACE INSIDE THE EXTRACTION REAGENT? 15-30 SECONDS. HOW LONG AFTER PROCESSING IN THE EXTRACTION REAGENT WAS THE SPECIMEN RUN ON THE TEST CARTRIDGE? RIGHT AWAY. HOW MANY DROPS WERE ADDED TO THE SAMPLE WELL ON THE TEST DEVICE? 3 DROPS. INCUBATION TIME: HOW LONG WAS SAMPLE RUN ON THE CARTRIDGE BEFORE READING? 15 MINUTES. WAS WALK-AWAY MODE USED OR ANALYZE NOW MODE? ANALYZE NOW. TEMPERATURE: CLARIFY THE ENVIRONMENT TEMPERATURE AND TIME OF TEST. WAS TESTING. PERFORMED INDOORS OR OUTDOORS (NOT COLLECTION)? INDOORS AT APPX 70 DEGREES FARENHEIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1481338 | BD VERITOR¿ SARS-COV-2 AND FLU A+B | NOT CLASSIFIED | QMN | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. | UNKNOWN | ||
| 1481344 | BD VERITOR¿ SARS-COV-2 AND FLU A+B | NOT CLASSIFIED | QMN | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |