BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
Report
- Report Number
- 1119779-2021-00985
- Event Type
- Malfunction
- Date Received
- June 10, 2021
- Date of Event
- May 19, 2021
- Report Date
- December 10, 2021
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- QKP
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE OR DISCREPANT RESULTS (OBSERVED TWO DIFFERENT RESULTS (COVID + AND COVID -) AFTER INSERTING THE SAME PATIENT TEST DEVICE INTO TWO DIFFERENT ANALYZERS) WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082), BATCH NUMBER 1090845. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE OR DISCREPANT RESULTS (OBSERVED TWO DIFFERENT RESULTS (COVID + AND COVID -) AFTER INSERTING THE SAME PATIENT TEST DEVICE INTO TWO DIFFERENT ANALYZERS) COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. A BATCH REVIEW WAS PERFORMED FOR THE NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE RETENTION TESTING COULD NOT BE TESTED AS THEY ARE EXPIRED. RETURNED PRODUCT TESTING COULD NOT BE COMPLETED A SAMPLES ARE EXPIRED. THERE ARE NO CURRENT TRENDS AGAINST FALSE POSITIVE OR DISCREPANT RESULTS (OBSERVED TWO DIFFERENT RESULTS (COVID + AND COVID -) AFTER INSERTING THE SAME PATIENT TEST DEVICE INTO TWO DIFFERENT ANALYZERS). BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. SEE H.10.
(B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. CARTRIDGE WAS REINSERTED INTO A DIFFERENT ANALYZER AND RESULT WAS NEGATIVE. TEST CARTRIDGES ARE SINGLE USE, AND MEANT TO BE READ ONE TIME BY THE VERITOR. ADDITIONAL CONFIRMATORY TESTING WAS NOT PERFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER REPORTED THAT SHE OBSERVED TWO DIFFERENT RESULTS (COVID + AND COVID -) AFTER INSERTING THE SAME PATIENT TEST DEVICE INTO TWO DIFFERENT ANALYZERS (SN (B)(6) AND SN (B)(6). 1.ASSAY KIT LOT NUMBER ( FOR THE AFFECTED RAPID DETECTION OF SARS-COV-2 VERITOR TEST KIT):1090845 2.WHAT TYPE OF SAMPLE WAS COLLECTED (NASAL OR NASOPHARYNGEAL PATIENT SAMPLE)? NASAL SAMPLE 3.WHICH SWAB WAS USED TO COLLECT THE SAMPLE (WAS IT THE SPECIMEN SAMPLING SWAB OR SARS COV +2 CONTROL SWABS WITHIN THE KIT)? SPECIMEN SAMPLING SWAB 4.HOW LONG AFTER COLLECTION WAS THE SWAB TESTED? IMMEDIATELY (FOLLOWED ALL THE INSTRUCTIONS PER PACKAGE INSERT) 5.WAS WALK-AWAY MODE USED OR ANALYZE NOW MODE? N/A 6.WERE THE KIT QUALITY CONTROL SWABS TESTED AND IF SO, DID THEY PASS? N/A 7.HOW LONG WAS THE SAMPLE INCUBATED? MORE THAN THE RECOMMENDED TIME, SINCE SHE HAD TO USE THE SAME PATIENT¿S TEST DEVICE TO INSERT INTO ANOTHER ANALYZER INSTEAD OF USING A NEW TEST DEVICE AND THE REST OF THE SAME PATIENT¿S PROCESSED SAMPLE TO REPEAT THE TEST (ON ANOTHER ANALYZER). THIS EXPLAINS WHY SHE OBSERVED THE INVALID RESULT (FALSE POSITIVE RESULT) ON THE SECOND ANALYZER, WHEREAS THE FIRST RESULT (ON THE FIRST ANALYZER) FOR THE PATIENT IN QUESTION WAS NEGATIVE [ COVID NEGATIVE (COVID -)] 8.HOW MANY DROPS WERE ADDED TO THE SAMPLE WELL ON THE TEST DEVICE? 3 DROPS 9.IS THE CUSTOMER REPORTING A FALSE POSITIVE OR FALSE NEGATIVE? FALSE POSITIVE 10.DID THE CUSTOMER VISUALLY INTERPRET THE RESULT, OR DID THEY INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? FROM THE ANALYZER, BUT SHE REPORTED THAT SHE SAW A RED LINE ON THE PATIENT¿S TEST DEVICE, AND SHE WAS ADVISED NOT TO VISUALLY READ THE DEVICE. 11.WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC.)? N/A 12.HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? 1 FP (CUSTOMER OBSERVED A FALSE POSITIVE OR AN INVALID RESULT, BECAUSE SHE DIDN¿T RESPECT THE BD TESTING PROCEDURE PER THE INSTRUCTION FOR USE FOR THE BD VERITOR SYSTEM FOR RAPID DETECTION OF SARS-COV-2) 13.HOW MANY KITS (RAPID DETECTION OF SARS-COV-2 VERITOR) WERE RECEIVED, AND QUANTITY AFFECTED? 1 RECEIVED AND NONE WERE AFFECTED (FOR THE CUSTOMER DIDN¿T RESPECT THE TEST PROCEDURE PER THE BD TESTING PROTOCOL) 14.WAS THE PATIENT SYMPTOMATIC OR ASYMPTOMATIC WHEN TESTED ON THE VERITOR PLUS ANALYZER? N/A 15.ON AVERAGE HOW MANY TESTS DO YOU RUN PER WEEK? N/A 16.WAS THERE ANY PATIENT IMPACTED BECAUSE OF THE FALSE RESULT? N/A.
IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. CARTRIDGE WAS REINSERTED INTO A DIFFERENT ANALYZER AND RESULT WAS NEGATIVE. TEST CARTRIDGES ARE SINGLE USE, AND MEANT TO BE READ ONE TIME BY THE VERITOR. ADDITIONAL CONFIRMATORY TESTING WAS NOT PERFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER REPORTED THAT SHE OBSERVED TWO DIFFERENT RESULTS (COVID + AND COVID -) AFTER INSERTING THE SAME PATIENT TEST DEVICE INTO TWO DIFFERENT ANALYZERS ((B)(4)). ASSAY KIT LOT NUMBER ( FOR THE AFFECTED RAPID DETECTION OF SARS-COV-2 VERITOR TEST KIT):(B)(4) WHAT TYPE OF SAMPLE WAS COLLECTED (NASAL OR NASOPHARYNGEAL PATIENT SAMPLE)? NASAL SAMPLE WHICH SWAB WAS USED TO COLLECT THE SAMPLE (WAS IT THE SPECIMEN SAMPLING SWAB OR SARS COV +2 CONTROL SWABS WITHIN THE KIT)? SPECIMEN SAMPLING SWAB HOW LONG AFTER COLLECTION WAS THE SWAB TESTED? IMMEDIATELY (FOLLOWED ALL THE INSTRUCTIONS PER PACKAGE INSERT) WAS WALK-AWAY MODE USED OR ANALYZE NOW MODE? N/A WERE THE KIT QUALITY CONTROL SWABS TESTED AND IF SO, DID THEY PASS? N/A HOW LONG WAS THE SAMPLE INCUBATED? MORE THAN THE RECOMMENDED TIME, SINCE SHE HAD TO USE THE SAME PATIENT¿S TEST DEVICE TO INSERT INTO ANOTHER ANALYZER INSTEAD OF USING A NEW TEST DEVICE AND THE REST OF THE SAME PATIENT¿S PROCESSED SAMPLE TO REPEAT THE TEST (ON ANOTHER ANALYZER). THIS EXPLAINS WHY SHE OBSERVED THE INVALID RESULT (FALSE POSITIVE RESULT) ON THE SECOND ANALYZER, WHEREAS THE FIRST RESULT (ON THE FIRST ANALYZER) FOR THE PATIENT IN QUESTION WAS NEGATIVE [ COVID NEGATIVE (COVID -)] HOW MANY DROPS WERE ADDED TO THE SAMPLE WELL ON THE TEST DEVICE? 3 DROPS IS THE CUSTOMER REPORTING A FALSE POSITIVE OR FALSE NEGATIVE? FALSE POSITIVE DID THE CUSTOMER VISUALLY INTERPRET THE RESULT, OR DID THEY INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? FROM THE ANALYZER, BUT SHE REPORTED THAT SHE SAW A RED LINE ON THE PATIENT¿S TEST DEVICE, AND SHE WAS ADVISED NOT TO VISUALLY READ THE DEVICE. WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC.)? N/A HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? 1 FP (CUSTOMER OBSERVED A FALSE POSITIVE OR AN INVALID RESULT, BECAUSE SHE DIDN¿T RESPECT THE BD TESTING PROCEDURE PER THE INSTRUCTION FOR USE FOR THE BD VERITOR SYSTEM FOR RAPID DETECTION OF SARS-COV-2) HOW MANY KITS (RAPID DETECTION OF SARS-COV-2 VERITOR) WERE RECEIVED, AND QUANTITY AFFECTED? 1 RECEIVED AND NONE WERE AFFECTED (FOR THE CUSTOMER DIDN¿T RESPECT THE TEST PROCEDURE PER THE BD TESTING PROTOCOL) WAS THE PATIENT SYMPTOMATIC OR ASYMPTOMATIC WHEN TESTED ON THE VERITOR PLUS ANALYZER? N/A ON AVERAGE HOW MANY TESTS DO YOU RUN PER WEEK? N/A WAS THERE ANY PATIENT IMPACTED BECAUSE OF THE FALSE RESULT? N/A
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 874892 | BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ | CORONAVIRUS ANTIGEN DETECTION SYSTEM | QKP | BECTON, DICKINSON & CO. (SPARKS) | 1090845 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |