BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
Report
- Report Number
- 1119779-2021-01839
- Event Type
- Malfunction
- Date Received
- November 17, 2021
- Date of Event
- October 21, 2021
- Report Date
- January 24, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- QKP
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082), BATCH NUMBER 1160730. PATIENT WAS TESTED AN HOUR LATER BY ANOTHER FACILITY AND TEST WAS NEGATIVE. 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 WAS PERFORMED ON THE BATCH NUMBER PROVIDED AND NO RELEVANT ISSUE WAS FOUND. RETENTION SAMPLE TESTING WAS NOT DONE BECAUSE THE MATERIAL HAD EXPIRED PRIOR TO THE COMPLAINT BEING REPORTED. BD MAKES NO CLAIMS ON EXPIRED PRODUCTS AND STABILITY STUDIES HAVE SHOWN THE USE OF EXPIRED MATERIALS MAY AFFECT THE SENSITIVITY OF THE ASSAY. THEREFORE, EXPIRED MATERIALS WILL NOT BE TESTED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. A TREND ANALYSIS FOR FALSE POSITIVE RESULTS WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. H3 OTHER TEXT : SEE H10.
(B)(4). THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 08 OCTOBER, 2021. MEDWATCH REPORT # MW5104508. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: DATE RECEIVED BY MANUFACTURER: 2021-10-20.
IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. PATIENT WENT TO A DIFFERENT CLINIC FOR TESTING AND THE RESULT WAS NEGATIVE. PATIENT WAS TESTED EACH DAY FOR 2 WEEKS WITH A NEGATIVE RESULT. TEST METHOD FOR NEGATIVE RESULTS WERE NOT REPORTED. PATIENT REPORTS THAT THE FALSE POSITIVE WAS NEVER CORRECTED BY FACILITY. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTER STATES SHE AND HER HUSBAND WENT TO SAMEDAY HEALTH FOR COVID TESTS TO BE CLEARED FOR THEIR FLIGHTS EUROPE THE NEXT DAY. SHE TESTED NEGATIVE BUT HER HUSBAND'S TESTED POSITIVE. REPORTS BOTH OF THEM ARE FULLY VACCINATED AND ARE PATHOLOGISTS KNOWLEDGEABLE ABOUT COVID. THE FACILITY TECH CAME TO THEIR CAR TO COLLECT SAMPLES. PATIENT OBSERVED POOR TESTING PRACTICES INCLUDING CONTAMINATION OF SWAB SAMPLE COLLECTION PLACING SWABS INTO UNMARKED, NON-STERILE BAGS. PATIENT'S HUSBAND RECEIVED A POSITIVE RESULT WHILE SHE RECEIVED A NEGATIVE RESULT. PATIENT WAS TESTED AN HOUR LATER BY ANOTHER FACILITY DOWN THE ROAD AND THAT TEST WAS NEGATIVE. SHE WAS TESTED EVERY DAY FOR THE NEXT TWO WEEKS AND RECEIVED NEGATIVE TEST RESULTS EACH DAY.
IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. PATIENT WENT TO A DIFFERENT CLINIC FOR TESTING AND THE RESULT WAS NEGATIVE. PATIENT WAS TESTED EACH DAY FOR 2 WEEKS WITH A NEGATIVE RESULT. TEST METHOD FOR NEGATIVE RESULTS WERE NOT REPORTED. PATIENT REPORTS THAT THE FALSE POSITIVE WAS NEVER CORRECTED BY FACILITY. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTER STATES SHE AND HER HUSBAND WENT TO SAME DAY HEALTH FOR COVID TESTS TO BE CLEARED FOR THEIR FLIGHTS TO EUROPE THE NEXT DAY. SHE TESTED NEGATIVE BUT HER HUSBAND'S TESTED POSITIVE. REPORTS BOTH OF THEM ARE FULLY VACCINATED AND ARE PATHOLOGISTS KNOWLEDGEABLE ABOUT COVID. THE FACILITY TECH CAME TO THEIR CAR TO COLLECT SAMPLES. PATIENT OBSERVED POOR TESTING PRACTICES INCLUDING CONTAMINATION OF SWAB SAMPLE COLLECTION PLACING SWABS INTO UNMARKED, NON-STERILE BAGS. PATIENT'S HUSBAND RECEIVED A POSITIVE RESULT WHILE SHE RECEIVED A NEGATIVE RESULT. PATIENT WAS TESTED AN HOUR LATER BY ANOTHER FACILITY DOWN THE ROAD AND THAT TEST WAS NEGATIVE. SHE WAS TESTED EVERY DAY FOR THE NEXT TWO WEEKS AND RECEIVED NEGATIVE TEST RESULTS EACH DAY.
IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. PATIENT WENT TO A DIFFERENT CLINIC FOR TESTING AND THE RESULT WAS NEGATIVE. PATIENT WAS TESTED EACH DAY FOR 2 WEEKS WITH A NEGATIVE RESULT. TEST METHOD FOR NEGATIVE RESULTS WERE NOT REPORTED. PATIENT REPORTS THAT THE FALSE POSITIVE WAS NEVER CORRECTED BY FACILITY. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTER STATES SHE AND HER HUSBAND WENT TO SAMEDAY HEALTH FOR COVID TESTS TO BE CLEARED FOR THEIR FLIGHTS EUROPE THE NEXT DAY. SHE TESTED NEGATIVE BUT HER HUSBAND'S TESTED POSITIVE. REPORTS BOTH OF THEM ARE FULLY VACCINATED AND ARE PATHOLOGISTS KNOWLEDGEABLE ABOUT COVID. THE FACILITY TECH CAME TO THEIR CAR TO COLLECT SAMPLES. PATIENT OBSERVED POOR TESTING PRACTICES INCLUDING CONTAMINATION OF SWAB SAMPLE COLLECTION PLACING SWABS INTO UNMARKED, NON-STERILE BAGS. PATIENT'S HUSBAND RECEIVED A POSITIVE RESULT WHILE SHE RECEIVED A NEGATIVE RESULT. PATIENT WAS TESTED AN HOUR LATER BY ANOTHER FACILITY DOWN THE ROAD AND THAT TEST WAS NEGATIVE. SHE WAS TESTED EVERY DAY FOR THE NEXT TWO WEEKS AND RECEIVED NEGATIVE TEST RESULTS EACH DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1728424 | BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ | CORONAVIRUS ANTIGEN DETECTION SYSTEM | QKP | BECTON, DICKINSON & CO. (SPARKS) | 1160730 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |