BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM
Report
- Report Number
- 1119779-2022-00003
- Event Type
- Malfunction
- Date Received
- January 6, 2022
- Date of Event
- December 10, 2021
- Report Date
- March 4, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- QJR
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
EUA # (B)(4). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD SARS-COV-2 REAGENTS (REF. 44500301) FROM LOT 1252944 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD SARS-COV-2 REAGENTS INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED SUSPECTED FALSE N1 POSITIVE RESULTS WITH BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM LOT 1252944. WHEN RETESTED, THE SAMPLES GAVE NEGATIVE SARS-COV-2 RESULTS. DATABASE OF INSTRUMENT CT1531 WAS PROVIDED FOR INVESTIGATION. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED, AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BD SARS-COV-2 REAGENTS INSTRUCTION FOR USE. ACCORDING TO CUSTOMER, 7 N1 POSITIVE PATIENT SAMPLES, IN FOUR DIFFERENT RUNS, WERE NEGATIVE UPON REPEAT. SINCE THE CUSTOMER DID NOT IDENTIFY IN WHICH RUNS THESE 7 SAMPLES WERE TESTED, ALL THE N1 POSITIVE / N2 NEGATIVE RESULTS OBTAINED WITH LOT 1252944 WERE EXAMINED. INSTRUMENT CT1531 DATABASE ANALYSIS REVEALED THAT ENVIRONMENTAL TESTS WERE PERFORMED ON (B)(6) 2021 AND THREE N1 POSITIVE RESULTS WERE OBTAINED. IT WAS OBSERVED THAT PUMP #3 WAS RESPONSIBLE FOR MOST OF THE N1 POSITIVE RESULTS AND A PUMP CONTAMINATION WAS SUSPECTED (AFFECTING A3 AND A7 LANE). BD INSTRUMENT QUALITY ENGINEER INDICATED THAT AN INSTRUMENT COMPLAINT WAS ALREADY OPENED TO ADDRESS THE INSTRUMENT SUSPECTED CONTAMINATION. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED ON THE OTHER N1 POSITIVE RESULTS. PCR CURVES ANALYSIS REVEALED LATE AND LOW, BUT TRUE AMPLIFICATIONS, FOR N1 TARGET WITHOUT ANOMALY, INDICATIVE OF TRUE POSITIVE RESULTS. LOW POSITIVE SAMPLES CAN OCCUR DUE TO VIRAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE DATA AND INFORMATION PROVIDED, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION, ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S DISCREPANT POSITIVE RESULTS. HOWEVER, BD WAS UNABLE TO IDENTIFY THE EXACT CAUSE OF THE ISSUE. NONETHELESS, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD SARS-COV-2 REAGENTS FROM LOT 1252944. THE ROOT CAUSE WAS NOT IDENTIFIED, HOWEVER SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) AND ENVIRONMENTAL, INSTRUMENT OR CROSS CONTAMINATION ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMERS POSITIVE RESULTS. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.
IT WAS REPORTED THAT WHILE TESTING WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, 7 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTING WAS PERFORMED, AND THE RESULTS WERE NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAD 7 PATIENT SAMPLES (OCCURRING OVER 4 DIFFERENT RUNS) THAT WERE COV-2 POSITIVE FOR THE N1 TARGET ON THE BD MAX CATALOG# 44500301, LOT# 1252944, BUT WERE NEGATIVE WHEN REPEATED.
IT WAS REPORTED THAT WHILE TESTING WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, 7 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTING WAS PERFORMED, AND THE RESULTS WERE NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAD 7 PATIENT SAMPLES (OCCURRING OVER 4 DIFFERENT RUNS) THAT WERE COV-2 POSITIVE FOR THE N1 TARGET ON THE BD MAX CATALOG# 44500301, LOT# 1252944, BUT WERE NEGATIVE WHEN REPEATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51591 | BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM | SARS-COV-2 REAGENT KIT | QJR | BECTON, DICKINSON & CO. (SPARKS) | 1252944 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |