KIT BD MAX EXT ENTERIC BACTERIAL PANEL
Report
- Report Number
- 1119779-2023-00980
- Event Type
- Malfunction
- Date Received
- September 12, 2023
- Date of Event
- August 3, 2023
- Report Date
- September 27, 2023
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- PCH
- UDI-DI
- 00382904438128
- PMA / PMN Number
- K170308
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL ASSAY (REF. 443812) FROM LOTS 2355384 AND 3066109, USED ALONG WITH THE BD MAX ENTERIC BACTERIAL PANEL WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT 3 DISCREPANT SAMPLES TESTED WITH BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL (XEBP) KIT, USED ALONG WITH THE BD MAX¿ ENTERIC BACTERIAL PANEL (EBP). IT MUST BE NOTED THAT THE DISCREPANCIES WERE OBSERVED ONLY WITH THE XEBP TARGETS, AND THE INVESTIGATION WAS THUS PERFORMED ON THE XEBP KIT LOTS. THE COMPLAINT TEXT ALSO MENTIONED UNDER RESULTS WITH CONTROL SAMPLES, BUT NO INFORMATION NOR DATA WAS PROVIDED THUS NO FURTHER INVESTIGATION COULD BE PERFORMED FOR THIS ISSUE. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL ASSAY INDICATED THAT LOTS 2355384 AND 3066109 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED SIX RUNS FILE (1206, 1209, 1324, 1326, 1344 AND 1346) FROM INSTRUMENT (B)(4) FOR INVESTIGATION. DATA ANALYSIS REVEALED THAT THE FIRST SAMPLE IN RUN 1206/POSITION A9 GAVE A VIBRIO POSITIVE RESULT (ROX CHANNEL) AND WHEN RETESTED IN RUN 1209/POSITION A4, IT GAVE A NEGATIVE RESULT FOR EVERY TARGET. THE SECOND SAMPLE IN RUN 1324/POSITION A9, INITIALLY GAVE A POSITIVE RESULT FOR BOTH VIBRIO AND YERSINIA TARGETS, DETECTED IN ROX AND FAM CHANNELS OF THE BOTTOM POSITION OF THE CARTRIDGE, BUT WHEN RETESTED TWICE (RUN 1326/A1 AND A2), IT GAVE A NEGATIVE RESULT FOR EVERY TARGETS. THE LAST SAMPLE, IN RUN 1344/POSITION A7, GAVE A POSITIVE RESULT FOR BOTH THE CAMPY AND YERSINIA TARGETS WHEN INITIALLY TESTED, DETECTED IN THE FAM CHANNEL OF THE TOP POSITION AND BOTTOM POSITION OF THE CARTRIDGE, RESPECTIVELY. HOWEVER, WHEN RETESTED TWICE (B5 AND B6 IN RUN 1346), IT GAVE A POSITIVE RESULT ONLY FOR THE CAMPY TARGET. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED ON THE DISCREPANT SAMPLES. FOR THE 3 SAMPLES (RUN 1206 LANE A9, RUN 1324 LANE A9 AND RUN 1344 LANE A7), ATYPICAL CURVES WERE OBSERVED IN ALL CHANNELS IN THE BOTTOM POSITION OF THE CARTRIDGE, WHICH LED TO POSITIVE RESULTS FOR THE VIBRIO AND/OR YERSINIA TARGETS. IT IS UNLIKELY THAT THESE ATYPICAL CURVES ARE DUE TO TRUE AMPLIFICATION AND A ROOT CAUSE COULD NOT BE IDENTIFIED. MOREOVER, THE REPEAT TEST SHOWED NO AMPLIFICATION NOR ANY ANOMALY, INDICATIVE OF TRUE NEGATIVE SAMPLES IN THE REPEAT TEST. HOWEVER, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR ABERRANT CURVE GEOMETRY IS A CONSERVATIVE ASSESSMENT OF THE DATA. THE ROOT CAUSE WAS NOT IDENTIFIED. 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 THE BD MAX¿ EXTENDED ENTERIC BACTERIAL PANEL LOTS 2355384 AND 3066109. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) SINCE NO NEW HAZARD WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.
H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
REPORT 2 OF 3. IT WAS REPORTED THAT WHILE USING KIT BD MAX EXT ENTERIC BACTERIAL PANEL THAT THERE WAS FALSE POSITIVES IN TWO LOTS. THEY EACH OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DID ERRONEOUS RESULTS OCCUR? YES IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): INCONSISTENT RESULT 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? INCONSISTENT RESULT 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) CONSISTENT RESULT 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? QC AND PATIENT 4. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? NO 5. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT? NO CUSTOMER BECAME CONCERNED THERE MAY BE AN ISSUE WITH THE ASSAY WHEN I HAD 3 POSITIVE VIBRIO RESULTS WITHIN A MONTH¿S TIME FROM PATIENT TESTING. AT THE START OF JUNE I REQUESTED THAT STAFF REPEAT ANY POSITIVE RESULTS THEY OBTAIN FOR VIBRIO IN DUPLICATE PRIOR TO REPORTING. THE SECOND INCIDENT OCCURRED AUGUST 3 (WHILE I WAS OFF ON VACATION). THE LATEST WAS AUGUST 9. DETAILS WILL BE PROVIDED BELOW. SINCE IT SEEMS TO BE VIBRIO AND YERSINIA WHICH ARE GIVING US THE FALSE POSITIVE RESULTS, I AM WONDERING IF THE ISSUE INVOLVED THE EXTENDED ENTERIC ASSAYS ONLY. ACCESSION #( B)(6), RUN#1206/1209, POSITION A9/A3 & A4, ENTERIC LOT# 3088948, EXTENDED LOT# 2355384, INITIAL RESULT VIBRIO + FINAL RESULT REPORTED VIBRIO NEG ACCESSION # (B)(6), RUN#1324/1326, POSITION A9/A1 & A2, ENTERIC LOT# 3081377, EXTENDED LOT# 3066109, INITIAL RESULT VIBRO + AND YERSINIA + FINAL RESULT REPORTED VIBRIO NEG AND YERSINIA NEG ACCESSION # (B)(6), RUN#1344/1346, POSITION A7/B5 & B6, ENTERIC LOT# 3081377, EXTENDED LOT# 3066109, INITIAL RESULT CAMPY + AND YERSINIA + FINAL RESULT REPORTED CAMPY + AND YERSINIA NEG CATALOG: 443812 EXTENDED ENTERIC LOTS INVOLVED: 2355384 (JUNE 13-14 TESTING), 3066109 (AUG. 3RD AND AUG. 9TH TESTING) ¿ HOW MANY BOXES OF THIS LOT NUMBER DID YOU RECEIVE IN TOTAL? 4 BOXES ¿ WHEN DID THIS ISSUE START? SUSPECT PRIOR TO JUNE 14TH BUT THAT IS THE DATE WE FIRST CONFIRMED THAT WE MAY BE GETTING ERRONEOUS RESULTS. ¿ PLEASE DESCRIBE ALL ISSUES NOTICED WITH THE KIT AND FOR WHICH TARGET ORGANISM /ANALYTES? FALSE POSITIVE RESULTS FOR VIBRIO AND YERSINIA OCCURRING ON AN INTERMITTENT BASIS ¿ WHAT KIND OF SAMPLES/SPECIMEN WERE BEING COLLECTED? FRESH, UNPRESERVED STOOL ¿ HOW MANY TIMES HAS THIS ISSUE OCCURRED? UNSURE OF PREVIOUSLY REPORTED RESULTS BUT SINCE MONITORING, HAVE HAD THREE INSTANCES WHERE REPEATED POSITIVE RESULTS DID NOT CONFIRM UPON REPEAT TESTING.
REPORT 2 OF 3. IT WAS REPORTED THAT WHILE USING KIT BD MAX EXT ENTERIC BACTERIAL PANEL THAT THERE WAS FASLE POSITIVES IN TWO LOTS. THEY EACH OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MON (B)(6) 2023 - PATIENT FIELDS UPDATED: DID ERRONEOUS RESULTS OCCUR? YES IF YES DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): INCONSISTENT RESULT 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? INCONSISTENT RESULT 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) CONSISTENT RESULT 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? QC AND PATIENT 4. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? NO 5. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT? NO CUSTOMER BECAME CONCERNED THERE MAY BE AN ISSUE WITH THE ASSAY WHEN I HAD 3 POSITIVE VIBRIO RESULTS WITHIN A MONTH¿S TIME FROM PATIENT TESTING. AT THE START OF JUNE I REQUESTED THAT STAFF REPEAT ANY POSITIVE RESULTS THEY OBTAIN FOR VIBRIO IN DUPLICATE PRIOR TO REPORTING. THE SECOND INCIDENT OCCURRED (B)(6) (WHILE I WAS OFF ON VACATION). THE LATEST WAS (B)(6). DETAILS WILL BE PROVIDED BELOW. SINCE IT SEEMS TO BE VIBRIO AND YERSINIA WHICH ARE GIVING US THE FALSE POSITIVE RESULTS, I¿M AM WONDERING IF THE ISSUE INVOLVED THE EXTENDED ENTERIC ASSAYS ONLY. ACCESSION (B)(6), RUN#1206/1209, POSITION A9/A3 & A4, ENTERIC LOT# 3088948, EXTENDED LOT# 2355384, INITIAL RESULT VIBRIO + FINAL RESULT REPORTED VIBRIO NEG ACCESSION #2321403879, RUN#1324/1326, POSITION A9/A1 & A2, ENTERIC LOT# 3081377, EXTENDED LOT# 3066109, INITIAL RESULT VIBRO + AND YERSINIA + FINAL RESULT REPORTED VIBRIO NEG AND YERSINIA NEG ACCESSION #2322001055, RUN#1344/1346, POSITION A7/B5 & B6, ENTERIC LOT# 3081377, EXTENDED LOT# 3066109, INITIAL RESULT CAMPY + AND YERSINIA + FINAL RESULT REPORTED CAMPY + AND YERSINIA NEG CATALOG: 443812 EXTENDED ENTERIC LOTS INVOLVED: 2355384 (JUNE 13-14 TESTING), 3066109 (AUG. 3RD AND AUG. 9TH TESTING) HOW MANY BOXES OF THIS LOT NUMBER DID YOU RECEIVE IN TOTAL? 4 BOXES WHEN DID THIS ISSUE START? SUSPECT PRIOR TO JUNE 14TH BUT THAT IS THE DATE WE FIRST CONFIRMED THAT WE MAY BE GETTING ERRONEOUS RESULTS. PLEASE DESCRIBE ALL ISSUES NOTICED WITH THE KIT AND FOR WHICH TARGET ORGANISM /ANALYTES? FALSE POSITIVE RESULTS FOR VIBRIO AND YERSINIA OCCURRING ON AN INTERMITTENT BASIS WHAT KIND OF SAMPLES/SPECIMEN WERE BEING COLLECTED? FRESH, UNPRESERVED STOOL ¿HOW MANY TIMES HAS THIS ISSUE OCCURRED? UNSURE OF PREVIOUSLY REPORTED RESULTS BUT SINCE MONITORING, HAVE HAD THREE INSTANCES WHERE REPEATED POSITIVE RESULTS DID NOT CONFIRM UPON REPEAT TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 861870 | KIT BD MAX EXT ENTERIC BACTERIAL PANEL | GASTROINTESTINAL PATHOGEN PANEL MULIPLEX NECLEIC ACID-BASED ASSAY SYSTEM | PCH | BECTON DICKINSON & CO. (SPARKS) | 3066109 | 00382904438128 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |