BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
Report
- Report Number
- 3006948883-2021-01010
- Event Type
- Malfunction
- Date Received
- November 19, 2021
- Date of Event
- October 27, 2021
- Report Date
- January 24, 2022
- Manufacturer
- BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
- Product Code
- QKP
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6: INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082), BATCH NUMBER 1213534. 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 ISSUE WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED.
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS AN EMERGENCY USE AUTHORIZATION. EUA# (B)(4).
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS AN EMERGENCY USE AUTHORIZATION. EUA# (B)(4).
IT WAS REPORTED WHILE TESTING WITH BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ A FALSE POSITIVE OCCURRED. THIS WAS REPORTED ONE TIME. THE PATIENT WAS TESTED A SECOND TIME PRIOR TO SURGERY, AND THAT RESULT WAS NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING ONE FP WITH 256082, LOT NUMBER 1213534. THE PATIENT WAS SCHEDULED FOR SURGERY TODAY AND WAS TESTED IN THE AM, WHICH OUTPUT A POSITIVE RESULT FOR COVID. THE PATIENT WAS THEN TESTED ONCE MORE PRIOR TO SURGERY, AND THAT RESULT WAS NEGATIVE. NO OTHER CONFIRMATORY TESTING WAS PERFORMED. QUANTITY RECEIVED AND QUANTITY AFFECTED: 3 BOXES, 1 AFFECTED CUSTOMER IS REPORTING ONE FP WITH 256082, LOT NUMBER 1213534.
IT WAS REPORTED WHILE TESTING WITH BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ A FALSE POSITIVE OCCURRED. THIS WAS REPORTED ONE TIME. THE PATIENT WAS TESTED A SECOND TIME PRIOR TO SURGERY, AND THAT RESULT WAS NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING ONE FP WITH 256082, LOT NUMBER 1213534. THE PATIENT WAS SCHEDULED FOR SURGERY TODAY AND WAS TESTED IN THE AM, WHICH OUTPUT A POSITIVE RESULT FOR COVID. THE PATIENT WAS THEN TESTED ONCE MORE PRIOR TO SURGERY, AND THAT RESULT WAS NEGATIVE. NO OTHER CONFIRMATORY TESTING WAS PERFORMED. § QUANTITY RECEIVED AND QUANTITY AFFECTED: 3 BOXES, 1 AFFECTED CUSTOMER IS REPORTING ONE FP WITH 256082, LOT NUMBER 1213534.
IT WAS REPORTED WHILE TESTING WITH BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ A FALSE POSITIVE OCCURRED. THIS WAS REPORTED ONE TIME. THE PATIENT WAS TESTED A SECOND TIME PRIOR TO SURGERY, AND THAT RESULT WAS NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING ONE FP WITH 256082, LOT NUMBER 1213534. THE PATIENT WAS SCHEDULED FOR SURGERY TODAY AND WAS TESTED IN THE AM, WHICH OUTPUT A POSITIVE RESULT FOR COVID. THE PATIENT WAS THEN TESTED ONCE MORE PRIOR TO SURGERY, AND THAT RESULT WAS NEGATIVE. NO OTHER CONFIRMATORY TESTING WAS PERFORMED. § QUANTITY RECEIVED AND QUANTITY AFFECTED: 3 BOXES, 1 AFFECTED CUSTOMER IS REPORTING ONE FP WITH 256082, LOT NUMBER 1213534.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1739819 | BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ | CORONAVIRUS ANTIGEN DETECTION SYSTEM | QKP | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. | 1213534 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |