BD VERITOR ¿ SARS-COV-2 & FLU A+B
Report
- Report Number
- 1119779-2021-01978
- Event Type
- Malfunction
- Date Received
- December 16, 2021
- Date of Event
- November 19, 2021
- Report Date
- March 1, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- QMN
- 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
CORRECTION: ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. THE FOLLOWING FIELDS HAVE BEEN UPDATED: A.2. AGE AT TIME OF EVENT: 3 A.2. AGE UNIT: DAY ( > 1 MONTH) A.2. DATE OF BIRTH: (B)(6) 2021 A.2. DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. B.3. DATE OF EVENT: (B)(6) 2021 B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 ON THE BD VERITOR ¿ SARS-COV-2 & FLU A+B, BOTH FALSE NEGATIVE COVID AND FALSE POSITIVE FLU RESULTS WERE PRODUCED. PCR TESTING WAS USED TO CONFIRM THE COVID RESULT AS POSITIVE, AND THE FLU RESULT AS NEGATIVE. THESE RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 4 RELATED INCIDENTS. H.6. IMDRF ANNEX A GRID: A090803, A090804.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 12/3/2021. H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES DISCREPANT RESULTS (4 FALSE POSITIVE AND 1 FALSE NEGATIVE) WHEN USING BD VERITOR¿ SARS-COV-2 AND FLU A+B (MATERIAL # 256088), BATCH NUMBER 1197689. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE DISCREPANT RESULTS (4 FALSE POSITIVE AND 1 FALSE NEGATIVE) 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. RETURNED PRODUCT TESTING WAS COMPLETED AND ALL DEVICES HAD NORMAL INTENDED RESULTS. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 ON THE BD VERITOR ¿ SARS-COV-2 & FLU A+B, BOTH FALSE NEGATIVE COVID AND FALSE POSITIVE FLU RESULTS WERE PRODUCED. PCR TESTING WAS USED TO CONFIRM THE COVID RESULT AS POSITIVE, AND THE FLU RESULT AS NEGATIVE. THESE RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 4 RELATED INCIDENTS. (B)(4) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS FOUR FALSE POSITIVES WITH 256088, LOT NUMBER IS UNKNOWN." "1. HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? 4 FP AND 1 FN BUT THERE WERE SEVERAL OTHER QUESTIONABLE RESULTS THAT WERE NOT CONFIRMED BY PCR 2. WHAT IS THE COLLECTION DATE AND TIME FOR EACH DISCREPANT SAMPLE? 11/17,11/18,11/19" "6. ASYMPTOMATIC PATIENTS OR DR. RECOMMENDED TESTING? NO ASYMPTOMATIC PATIENTS TESTED 7. DID YOU VISUALLY INTERPRET THE RESULT OR DID YOU INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? RESULTS ARE READ BY THE BD DEVICE 8. WERE THE KIT QC SWABS TESTED AND IF SO, DID THEY PASS? THE VERIFICATION CARTRIDGE, ALONG WITH ALL 3 QC ARE PERFORMED AND DOCUMENTED PRIOR TO PATIENT TESTING. ALL QC PASSED. 9. WAS THERE PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? ONE PATIENT DID NOT RECEIVE COVID RESULTS FOR 48 HRS, SINCE AG TEST WAS NEGATIVE 10. IF YES, WERE RESULTS REPORTED TO A MEDICAL DOCTOR? ALL RESULTS REPORTED TO THE MEDICAL DIRECTOR AND PROVIDER IMMEDIATELY 11. IF YES, DID THE PATIENT RECEIVE TREATMENT? YES 12. IF YES, ANY ADVERSE EFFECT ON THE PATIENT? NOT THAT WE ARE AWARE OF" "CUSTOMER REPORTS FOUR FALSE POSITIVES WITH 256088, LOT NUMBER 1197689. ADDITIONALLY, THERE WAS A REPORT OF 1 FN ASSOCIATED WITH A SEPARATE (B)(4)."
IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 ON THE BD VERITOR ¿ SARS-COV-2 & FLU A+B, BOTH FALSE NEGATIVE COVID AND FALSE POSITIVE FLU RESULTS WERE PRODUCED. PCR TESTING WAS USED TO CONFIRM THE COVID RESULT AS POSITIVE, AND THE FLU RESULT AS NEGATIVE. THESE RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 4 RELATED INCIDENTS. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS FOUR FALSE POSITIVES WITH 256088, LOT NUMBER IS UNKNOWN." "1. HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? 4 FP AND 1 FN BUT THERE WERE SEVERAL OTHER QUESTIONABLE RESULTS THAT WERE NOT CONFIRMED BY PCR 2. WHAT IS THE COLLECTION DATE AND TIME FOR EACH DISCREPANT SAMPLE? 11/17,11/18,11/19" "6. ASYMPTOMATIC PATIENTS OR DR. RECOMMENDED TESTING? NO ASYMPTOMATIC PATIENTS TESTED 7. DID YOU VISUALLY INTERPRET THE RESULT OR DID YOU INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? RESULTS ARE READ BY THE BD DEVICE 8. WERE THE KIT QC SWABS TESTED AND IF SO, DID THEY PASS? THE VERIFICATION CARTRIDGE, ALONG WITH ALL 3 QC ARE PERFORMED AND DOCUMENTED PRIOR TO PATIENT TESTING. ALL QC PASSED. 9. WAS THERE PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? ONE PATIENT DID NOT RECEIVE COVID RESULTS FOR 48 HRS, SINCE AG TEST WAS NEGATIVE 10. IF YES, WERE RESULTS REPORTED TO A MEDICAL DOCTOR? ALL RESULTS REPORTED TO THE MEDICAL DIRECTOR AND PROVIDER IMMEDIATELY 11. IF YES, DID THE PATIENT RECEIVE TREATMENT? YES 12. IF YES, ANY ADVERSE EFFECT ON THE PATIENT? NOT THAT WE ARE AWARE OF" "CUSTOMER REPORTS FOUR FALSE POSITIVES WITH 256088, LOT NUMBER 1197689. ADDITIONALLY, THERE WAS A REPORT OF 1 FN ASSOCIATED WITH A SEPARATE CASE- # (B)(4)."
IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 ON THE BD VERITOR ¿ SARS-COV-2 & FLU A+B, A FALSE POSITIVE RESULT WAS OBTAINED. PCR TESTING WAS USED TO CONFIRM THE RESULT WAS NEGATIVE. RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 4 RELATED INCIDENTS. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS FOUR FALSE POSITIVES WITH 256088, LOT NUMBER IS UNKNOWN." "HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? 4 FP AND 1 FN BUT THERE WERE SEVERAL OTHER QUESTIONABLE RESULTS THAT WERE NOT CONFIRMED BY PCR. WHAT IS THE COLLECTION DATE AND TIME FOR EACH DISCREPANT SAMPLE? 11/17,11/18,11/19" "ASYMPTOMATIC PATIENTS OR DR. RECOMMENDED TESTING? NO ASYMPTOMATIC PATIENTS TESTED. DID YOU VISUALLY INTERPRET THE RESULT OR DID YOU INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? RESULTS ARE READ BY THE BD DEVICE. WERE THE KIT QC SWABS TESTED AND IF SO, DID THEY PASS? THE VERIFICATION CARTRIDGE, ALONG WITH ALL 3 QC ARE PERFORMED AND DOCUMENTED PRIOR TO PATIENT TESTING. ALL QC PASSED. WAS THERE PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? ONE PATIENT DID NOT RECEIVE COVID RESULTS FOR 48 HRS, SINCE AG TEST WAS NEGATIVE. IF YES, WERE RESULTS REPORTED TO A MEDICAL DOCTOR? ALL RESULTS REPORTED TO THE MEDICAL DIRECTOR AND PROVIDER IMMEDIATELY. IF YES, DID THE PATIENT RECEIVE TREATMENT? YES. IF YES, ANY ADVERSE EFFECT ON THE PATIENT? NOT THAT WE ARE AWARE OF". "CUSTOMER REPORTS FOUR FALSE POSITIVES WITH 256088, LOT NUMBER 1197689. ADDITIONALLY, THERE WAS A REPORT OF 1 FN ASSOCIATED WITH A SEPARATE (B)(4)."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1920690 | BD VERITOR ¿ SARS-COV-2 & FLU A+B | NOT CLASSIFIED | QMN | BECTON, DICKINSON & CO. (SPARKS) | 1197689 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 DA | Unknown |