BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
Report
- Report Number
- 3006948883-2022-00001
- Event Type
- Malfunction
- Date Received
- January 18, 2022
- Date of Event
- December 23, 2021
- Report Date
- March 23, 2022
- Manufacturer
- BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
- Product Code
- QKP
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES DISCREPANT RESULT WHEN USING RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082), BATCH NUMBER 1261757. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE DISCREPANT RESULT 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. RETURNED PRODUCT TESTING WAS COMPLETED AND ALL DEVICES HAD NORMAL INTENDED RESULTS. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.
IT WAS REPORTED WHILE TESTING FOR SARS-COV-2, THE BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ PRODUCED A FALSE NEGATIVE RESULT DESPITE CLEARLY SHOWING THREE VISIBLE LINES. ANOTHER TEST CARTRIDGE WAS USED WHICH PRODUCED A POSITIVE RESULT. THE PHYSICIAN WAS MADE AWARE OF THE RESULTS, AND THERE WAS NO ADVERSE PATIENT IMPACT. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A CUSTOMER'S COVID KIT IS GIVING INCONSISTENT RESULTS." "REACHED OUT TO CUSTOMER AND WAS TOLD THAT THEY HAD A TEST CARTRIDGE THAT HAD 3 CLEARLY VISIBLE LINES BUT GAVE A NEGATIVE RESULT WHEN INSERTED INTO THEIR ANALYZER. CUSTOMER SAID THEY REPEATED THE SET UP USING A NEW TEST CARTRIDGE WITH FRESH SPECIMEN AND THE TEST CARTRIDGE STILL HAD 3 VISIBLE TEST LINES AND GAVE A POSITIVE RESULT WHEN INSERTED INTO THEIR ANALYZER. THEIR PHYSICIAN GOT CONCERNED SO THEY EMAILED MEDICAL AFFAIRS... VERIFIED PROPER WORKFLOW AND ANALYZER WORKING FINE... REMINDED CUSTOMER THAT THE VERITOR ANALYZER MUST BE USED FOR INTERPRETATION OF ALL TEST RESULTS AND THAT OPERATORS SHOULD NOT ATTEMPT TO INTERPRET ASSAY RESULTS DIRECTLY FROM THE TEST CARTRIDGE." HOW WAS THE SPECIMEN COLLECTED? DID IT FOLLOW THE DUAL-NARES COLLECTION METHOD. DESCRIBED IN THE QRI? YES. WHAT TYPE OF SWAB WAS USED TO COLLECT THE SPECIMEN? SWAB FROM KIT. WAS ANY TRANSPORT MEDIA USED? N/A. WHAT DATE WAS THE SPECIMEN COLLECTED? (B)(6) 2021. WHAT DATE WAS THE SPECIMEN RUN? (B)(6) 2021. WAS PATIENT SYMPTOMATIC OR ASYMPTOMATIC? SYMPTOMATIC. HOW WAS IT DETERMINED TO BE DISCREPANT? FIRST CASSETTE READ NEGATIVE, SECOND CASSETTE READ POSITIVE FROM SAME SAMPLE. COMPARISON TO ANOTHER METHOD? N/A. PROVIDE DETAIL- N/A. REPEATED SAMPLE? REPEATED WITH SAME SAMPLE. HOW WAS THE REPEAT TEST COMPLETED? SAME WITH PREVIOUS. WAS AN ADDITIONAL SWAB COLLECTED? NO. WAS THE SAME SWAB PROCESSED IN A 2ND REAGENT TUBE? NO. WAS LEFTOVER EXTRACTION REAGENT USED FROM THE REAGENT TUBE ON A NEW CARTRIDGE? YES. WAS THE CARTRIDGE RERUN (RE-READ)? IF SO, HOW LONG AFTER THE INITIAL RUN WAS THE CARTRIDGE RERUN (RE-READ)? APPROX 15-20 MINS REREAD 1ST CARTRIDGE- STILL NEGATIVE RESULTS. WAS THE TEST CARTRIDGE READ VISUALLY? NO, BY READER/BD ANALYZER - VISUAL INSPECTION SHOWED 3 LINES ON BOTH TEST CARTRIDGES." "HOW LONG AFTER SPECIMEN COLLECTION WAS THE SPECIMEN PROCESSED IN THE EXTRACTION REAGENT? IMMEDIATELY. HOW WAS THE SPECIMEN STORED BETWEEN COLLECTION AND PROCESSING IN THE EXTRACTION REAGENT? IMMEDIATELY. HOW LONG AFTER PROCESSING IN THE EXTRACTION REAGENT WAS THE SPECIMEN RUN ON THE TEST CARTRIDGE? IMMEDIATELY. INCUBATION TIME: HOW LONG WAS SAMPLE RUN ON THE CARTRIDGE BEFORE READING? 15 MINS TEMPERATURE: CLARIFY THE ENVIRONMENT TEMPERATURE AND TIME AT TEMP - ROOM TEMP 72*" "IS THE CUSTOMER REPORTING A FALSE POSITIVE OR FALSE NEGATIVE? FALSE NEGATIVE DID THE CUSTOMER VISUALLY INTERPRET THE RESULT OR DID THEY INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? BOTH. 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 FN. WAS THE PATIENT(S) SYMPTOMATIC WHEN TESTED ON THE VERITOR PLUS ANALYZER: YES. WERE PATIENTS SYMPTOMATIC OR ASYMPTOMATIC? SYMPTOMATIC. SCREENING TEST ¿ NO KNOWN EXPOSURE? YES. SCREENING TEST - KNOWN EXPOSURE THAT IS CURRENTLY ASYMPTOMATIC? NO. SYMPTOMATIC BUT DR RECOMMENDED TESTING? NO. ON AVERAGE HOW MANY TESTS DO YOU RUN PER WEEK? VARIES. WAS THERE ANY PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? NO."
IT WAS REPORTED WHILE TESTING FOR SARS-COV-2, THE BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ PRODUCED A FALSE NEGATIVE RESULT DESPITE CLEARLY SHOWING THREE VISIBLE LINES. ANOTHER TEST CARTRIDGE WAS USED WHICH PRODUCED A POSITIVE RESULT. THE PHYSICIAN WAS MADE AWARE OF THE RESULTS, AND THERE WAS NO ADVERSE PATIENT IMPACT. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A CUSTOMER'S COVID KIT IS GIVING INCONSISTENT RESULTS." "REACHED OUT TO CUSTOMER AND WAS TOLD THAT THEY HAD A TEST CARTRIDGE THAT HAD 3 CLEARLY VISIBLE LINES BUT GAVE A NEGATIVE RESULT WHEN INSERTED INTO THEIR ANALYZER. CUSTOMER SAID THEY REPEATED THE SET UP USING A NEW TEST CARTRIDGE WITH FRESH SPECIMEN AND THE TEST CARTRIDGE STILL HAD 3 VISIBLE TEST LINES AND GAVE A POSITIVE RESULT WHEN INSERTED INTO THEIR ANALYZER. THEIR PHYSICIAN GOT CONCERNED SO THEY EMAILED MEDICAL AFFAIRS... VERIFIED PROPER WORKFLOW AND ANALYZER WORKING FINE... REMINDED CUSTOMER THAT THE VERITOR ANALYZER MUST BE USED FOR INTERPRETATION OF ALL TEST RESULTS AND THAT OPERATORS SHOULD NOT ATTEMPT TO INTERPRET ASSAY RESULTS DIRECTLY FROM THE TEST CARTRIDGE." "1. HOW WAS THE SPECIMEN COLLECTED? DID IT FOLLOW THE DUAL-NARES COLLECTION METHOD DESCRIBED IN THE QRI? YES 2. WHAT TYPE OF SWAB WAS USED TO COLLECT THE SPECIMEN? SWAB FROM KIT A. WAS ANY TRANSPORT MEDIA USED? N/A 3. WHAT DATE WAS THE SPECIMEN COLLECTED? 12/23/2021 4. WHAT DATE WAS THE SPECIMEN RUN? 12/23/2021 5. WAS PATIENT SYMPTOMATIC OR ASYMPTOMATIC? SYMPTOMATIC 6. HOW WAS IT DETERMINED TO BE DISCREPANT? FIRST CASSETTE READ NEGATIVE, SECOND CASSETTE READ POSITIVE FROM SAME SAMPLE A. COMPARISON TO ANOTHER METHOD? N/A I. PROVIDE DETAIL- N/A B. REPEATED SAMPLE? REPEATED WITH SAME SAMPLE 7. HOW WAS THE REPEAT TEST COMPLETED? SAME WITH PREVIOUS A. WAS AN ADDITIONAL SWAB COLLECTED? NO B. WAS THE SAME SWAB PROCESSED IN A 2ND REAGENT TUBE? NO WAS LEFTOVER EXTRACTION REAGENT USED FROM THE REAGENT TUBE ON A NEW CARTRIDGE? YES C. WAS THE CARTRIDGE RERUN (RE-READ)? IF SO, HOW LONG AFTER THE INITIAL RUN WAS THE CARTRIDGE RERUN (RE-READ)? APPROX 15-20 MINS REREAD 1ST CARTRIDGE- STILL NEGATIVE RESULTS D. WAS THE TEST CARTRIDGE READ VISUALLY? NO, BY READER/BD ANALYZER - VISUAL INSPECTION SHOWED 3 LINES ON BOTH TEST CARTRIDGES" "1. HOW LONG AFTER SPECIMEN COLLECTION WAS THE SPECIMEN PROCESSED IN THE EXTRACTION REAGENT? IMMEDIATELY 2. HOW WAS THE SPECIMEN STORED BETWEEN COLLECTION AND PROCESSING IN THE EXTRACTION REAGENT? IMMEDIATELY 3. HOW LONG AFTER PROCESSING IN THE EXTRACTION REAGENT WAS THE SPECIMEN RUN ON THE TEST CARTRIDGE? IMMEDIATELY 4. INCUBATION TIME: HOW LONG WAS SAMPLE RUN ON THE CARTRIDGE BEFORE READING? 15 MINS 5. TEMPERATURE: CLARIFY THE ENVIRONMENT TEMPERATURE AND TIME AT TEMP - ROOM TEMP 72*" "IS THE CUSTOMER REPORTING A FALSE POSITIVE OR FALSE NEGATIVE? FALSE NEGATIVE DID THE CUSTOMER VISUALLY INTERPRET THE RESULT OR DID THEY INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? BOTH 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 FN WAS THE PATIENT(S) SYMPTOMATIC WHEN TESTED ON THE VERITOR PLUS ANALYZER: YES WERE PATIENTS SYMPTOMATIC OR ASYMPTOMATIC? SYMPTOMATIC 1. SCREENING TEST ¿ NO KNOWN EXPOSURE? YES 2. SCREENING TEST - KNOWN EXPOSURE THAT IS CURRENTLY ASYMPTOMATIC? NO 3. ASYMPTOMATIC BUT DR RECOMMENDED TESTING? NO ON AVERAGE HOW MANY TESTS DO YOU RUN PER WEEK? VARIES WAS THERE ANY PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? NO"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1036303 | BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ | CORONAVIRUS ANTIGEN DETECTION SYSTEM | QKP | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. | 1261757 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |