BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM
Report
- Report Number
- 1119779-2022-00610
- Event Type
- Malfunction
- Date Received
- April 27, 2022
- Date of Event
- March 28, 2022
- Report Date
- June 9, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- QJR
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
(B)(4). DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS (REF. (B)(4)) LOTS 2011863, 1355222, 1340798 AND 2018237 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA, AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD SARS-COV-2 REAGENTS INDICATED THAT LOTS 2011863, 1355222, 1340798 AND 2018237 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT DISCREPANT RESULTS OBTAINED WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KITS FROM LOTS 2011863, 1355222, 1340798 AND 2018237. DATABASE OF BD MAX¿ INSTRUMENT CT1844 WAS RECEIVED ALONG WITH SEVERAL RUN FILES (948, 950, 951, 952, 953, 956, 961, 962, 963, 967, 969, 973, 984, 989, 994, 1000, 1001, 1002 AND 1003). THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED, AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BD SARS-COV-2 REAGENT¿S INSTRUCTION FOR USE. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED ACROSS THE 24 DISCREPANT RESULTS. ANALYSIS OF PCR CURVES OF THESE SAMPLES REVEALED LATE AND LOW, BUT TRUE AMPLIFICATION FOR N1 AND/OR N2 TARGET WITHOUT ANOMALY INDICATIVE OF TRUE LOW POSITIVE RESULTS FOR ALL THE SAMPLES, INCLUDING ENVIRONMENTAL MONITORING AND NEGATIVE QC SAMPLES. 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. MOREOVER, THE CUSTOMER¿S DISCREPANT RESULTS OCCURRED WITH MULTIPLE LOTS, SUGGESTING THE ISSUE IS NOT LINKED TO A SPECIFIC KIT LOT. THE DATA ANALYSIS ALSO REVEALED THAT THE DISCREPANT RESULTS IDENTIFIED IN THE COMPLAINT TEXT ARE MOSTLY OBTAINED ON POSITIONS LINKED TO INSTRUMENT PUMP #3 (17 OUT OF 24 DISCREPANT SAMPLES) FURTHER SUPPORTING A POTENTIAL CONTAMINATION HYPOTHESIS. IT IS TO BE NOTED THAT PUMP #3 WAS REPLACED DURING THE MOST RECENT FSE VISIT FOR AN UNRELATED MATTER (NOT LINKED TO CONTAMINATION). SINCE THIS PUMP REPLACEMENT, IT IS POSSIBLE THAT THE RATE OF DISCREPANT RESULTS, HAS DECREASED, BUT BECAUSE NO DATA WAS AVAILABLE FOLLOWING THE PUMP REPLACEMENT, BD CANNOT CONFIRM THE HYPOTHESIS. 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, ENVIRONMENTAL TARGET CONTAMINATION (MOSTLY ASSOCIATED WITH PUMP #3) IS THE MOST LIKELY CAUSE TO EXPLAIN MOST OF THE CUSTOMER¿S POSITIVE RESULTS. SAMPLE AT THE ASSAY LOD IS ALSO A POSSIBLE ROOT CAUSE. 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 KIT LOTS 2011863, 1355222, 1340798 AND 2018237. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, ENVIRONMENTAL, OR CROSS CONTAMINATION ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULTS. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) SINCE NO REAGENT ISSUE WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.
REPORT 8 OF 20. IT WAS REPORTED THAT DURING USE WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED ON THE CEPHEID ANALYZER, AND THE RESULT WAS NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RUN 953 POSITION A11 ACCESSION 822084 (POSITIVE) - REPEATED NEGATIVE ON CEPHEID ANALYZER (B)(6) 2022 CUSTOMER REPORTS A DISCREPANT RESULTS WITH 44500301. CUSTOMER HAS INDICATED HAVING TO REPEAT SEVERAL PATIENT SAMPLES DUE TO SO MANY INSTANCES OF DISCREPANT RESULTS AS OF LATE. THE FACILITY'S NORMAL PROCEDURE IS TO REPEAT ANY POS RESULT OUTPUT BY THE BD MAX. IN THE PAST, THE CUSTOMER HAS STATED NOT HAVING ANY ISSUES AFTER REPEATING, BUT NOTICED AN INCREASE IN NEG RESULTS ON REPEAT. THE MEDICAL INFORMATION SERVICES TEAM HAS REACHED OUT TO CUSTOMER AND PROVIDED THEM INFORMATION PERTAINING TO THE INCREASE IN THEIR N1 POSITIVITY RATE, HOWEVER, THE CUSTOMER HAS EXPRESSED WANTING A MORE THOROUGH INVESTIGATION. RUN AND DATABASE FILES HAVE BEEN RECEIVED FROM THE CUSTOMER AND SAVED TO THE Q DRIVE FOR VISIBILITY. INCIDENT DATE(S): (B)(6) 2022 - (B)(6) 2022. INSTRUMENT SN AND SW VERSION: (B)(4). REFERENCE AND LOT NUMBERS OF REAGENT'S KITS: 44500301,2011863,1340798, 2018237. HOW MANY KITS OF THIS LOT WERE RECEIVED? HOW MANY WERE USED WHEN DISCREPANT RESULT OCCURRED? UNKNOWN. WHICH ASSAY EXPERIENCED THE DISCREPANT RESULT AND FOR WHICH TARGET ORGANISM/ANALYTE? SARS-COV-2 445003-01 SARS COV2. SAMPLES AFFECTED (PATIENT OR EXTERNAL CONTROL): PATIENT, EXTERNAL CONTROL, AND EM . SAMPLE COLLECTION MEDIA TYPE AND SIZE (1ML/3ML, ETC.): 3ML. WHAT DO YOU USE FOR EXTERNAL CONTROLS AND HOW DO YOU PREPARE THEM? HELIX ELITE NEG CELLULARITY CONTROL, SERACARE POSITIVE CONTROL. PREPARED PER INSTRUCTIONS WITH REAGENT GRADE WATER. THERE HAVE BEEN RUNS BETWEEN THESE WITH ALL NEGATIVE PATIENTS, QC OK, AND WITH MANY EM SWABS RUNS THAT ARE NEGATIVE. (B)(4) . PLEASE INCLUDE ACCESSION NUMBER, RUN#, SAMPLE POSITION, LOT# AND FINAL RESULTS REPORTED FOR EACH PATIENT, IF APPLICABLE. SEE ABOVE. ALL PATIENTS RESULTED CORRECTLY AS NEGATIVE. WE HAVE PUT IN PLACE A POLICY TO REPEAT ANY POSITIVE RESULT FROM THE BD MAX BEFORE RESULTING. HAS ANY OF THE SAMPLES AFFECTED BEEN REPEATED? YES, ALL OF THEM. ALL HAVE REPEATED NEGATIVE ON CEPHEID OR ON REPEAT RUN ON MAX. SOME OF THE ORIGINAL SBT TUBES REPEAT AS NEGATIVE, PROVING NO CONTAMINATION INSIDE THE SBT. WHAT ARE THE RESULTS OF YOUR MOST RECENT ENVIRONMENTAL MONITORING RUN? NEGATIVE. WHICH TEST IS USED FOR CONFIRMATION? CONFIRMATION TESTING DATE(S): CEPHEID SARS COV/FLU/RSV. FOR IND ERRORS, NAVIGATE TO MAINTENANCE TAB AND THEN EVENT VIEWER TAB, WHAT IS THE ALERT DESCRIPTION? N/A. FINAL RESULTS REPORTED TO CLINICIAN: NEGATIVE. ADVERSE EFFECT ON PATIENT, IF ANY: NO . TREATMENT OR MEDICATIONS RECEIVED BY THE PATIENT, IF ANY: NO. HAS MAX ASSAY UDP/ADF BEEN VERIFIED AND WHICH VERSION ARE CURRENTLY USING (N/A IF ANOTHER ASSAY) IS YOUR BD MAX CONNECTED REMOTELY TO BD VIA ASSURITY-LINC OR RSS? NO. CAN YOU PROVIDE RUN REPORTS (2 FILES FOR EACH RUN; PDF AND .CSV) VIA EMAIL?
IT WAS REPORTED THAT DURING USE WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED ON THE CEPHEID ANALYZER, AND THE RESULT WAS 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: RUN 953 POSITION A11 ACCESSION 822084 (POSITIVE) - REPEATED NEGATIVE ON CEPHEID ANALYZER 3/14/22 CUSTOMER REPORTS A DISCREPANT RESULTS WITH 44500301. CUSTOMER HAS INDICATED HAVING TO REPEAT SEVERAL PATIENT SAMPLES DUE TO SO MANY INSTANCES OF DISCREPANT RESULTS AS OF LATE. THE FACILITY'S NORMAL PROCEDURE IS TO REPEAT ANY POS RESULT OUTPUT BY THE BD MAX. IN THE PAST, THE CUSTOMER HAS STATED NOT HAVING ANY ISSUES AFTER REPEATING, BUT NOTICED AN INCREASE IN NEG RESULTS ON REPEAT. THE MEDICAL INFORMATION SERVICES TEAM HAS REACHED OUT TO CUSTOMER AND PROVIDED THEM INFORMATION PERTAINING TO THE INCREASE IN THEIR N1 POSITIVITY RATE, HOWEVER, THE CUSTOMER HAS EXPRESSED WANTING A MORE THOROUGH INVESTIGATION. RUN AND DATABASE FILES HAVE BEEN RECEIVED FROM THE CUSTOMER AND SAVED TO THE Q DRIVE FOR VISIBILITY. ¿ INCIDENT DATE(S): 3/11/22 - 4/5/22. ¿ INSTRUMENT SN AND SW VERSION: V5.14A. .¿ REFERENCE AND LOT NUMBERS OF REAGENT'S KITS: 44500301,2011863,1340798, 2018237. -HOW MANY KITS OF THIS LOT WERE RECEIVED? HOW MANY WERE USED WHEN DISCREPANT RESULT OCCURRED? UNKNOWN ¿ WHICH ASSAY EXPERIENCED THE DISCREPANT RESULT AND FOR WHICH TARGET ORGANISM/ANALYTE? SARS-COV-2 445003-01 SARS COV2. ¿ SAMPLES AFFECTED (PATIENT OR EXTERNAL CONTROL): PATIENT, EXTERNAL CONTROL, AND EM ¿ SAMPLE COLLECTION MEDIA TYPE AND SIZE (1ML/3ML, ETC.): 3ML ¿ WHAT DO YOU USE FOR EXTERNAL CONTROLS AND HOW DO YOU PREPARE THEM? HELIX ELITE NEG CELLULARITY CONTROL, SERACARE POSITIVE CONTROL. PREPARED PER INSTRUCTIONS WITH REAGENT GRADE WATER. THERE HAVE BEEN RUNS BETWEEN THESE WITH ALL NEGATIVE PATIENTS, QC OK, AND WITH MANY EM SWABS RUNS THAT ARE NEGATIVE. (B)(6) : 2022-04-05 13:15:39 (GMT). ¿ PLEASE INCLUDE ACCESSION NUMBER, RUN#, SAMPLE POSITION, LOT# AND FINAL RESULTS REPORTED FOR EACH PATIENT, IF APPLICABLE. SEE ABOVE. ALL PATIENTS RESULTED CORRECTLY AS NEGATIVE. WE HAVE PUT IN PLACE A POLICY TO REPEAT ANY POSITIVE RESULT FROM THE BD MAX BEFORE RESULTING. ¿ HAS ANY OF THE SAMPLES AFFECTED BEEN REPEATED? YES, ALL OF THEM. ALL HAVE REPEATED NEGATIVE ON CEPHEID OR ON REPEAT RUN ON MAX. SOME OF THE ORIGIANL SBT TUBES REPEAT AS NEGATIVE, PROVING NO CONTAMINATION INSIDE THE SBT. ¿ WHAT ARE THE RESULTS OF YOUR MOST RECENT ENVIRONMENTAL MONITORING RUN? NEGATIVE ¿ WHICH TEST IS USED FOR CONFIRMATION? ____ CONFIRMATION TESTING DATE(S):______ CEPHEID SARS COV/FLU/RSV ¿ FOR IND ERRORS, NAVIGATE TO MAINTENANCE TAB AND THEN EVENT VIEWER TAB, WHAT IS THE ALERT DESCRIPTION? N/A ¿ FINAL RESULTS REPORTED TO CLINICIAN: ________ NEGATIVE. .¿ ADVERSE EFFECT ON PATIENT, IF ANY: _______ NO. ¿ TREATMENT OR MEDICATIONS RECEIVED BY THE PATIENT, IF ANY: _______________NO. ¿ HAS MAX ASSAY UDP/ADF BEEN VERIFIED AND WHICH VERSION ARE CURRENTLY USING (N/A IF ANOTHER ASSAY)? ¿ IS YOUR BD MAX CONNECTED REMOTELY TO BD VIA ASSURITY-LINC OR RSS? NO. -CAN YOU PROVIDE RUN REPORTS (2 FILES FOR EACH RUN; PDF AND .CSV) VIA EMAIL?
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1495457 | BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM | SARS-COV-2 REAGENT KIT | QJR | BECTON, DICKINSON & CO. (SPARKS) | 2011863 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |