BD MULTITEST¿
Report
- Report Number
- 2916837-2021-00390
- Event Type
- Malfunction
- Date Received
- October 8, 2021
- Date of Event
- September 1, 2021
- Report Date
- February 7, 2022
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- GKZ
- UDI-DI
- 00382903389605
- PMA / PMN Number
- K062087
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH BD MULTITEST¿ ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. D.1. MEDICAL DEVICE BRAND NAME: BD MULTITEST¿ D.1 MEDICAL DEVICE TYPE: NA D.2. COMMON DEVICE NAME: NA D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON CARIBE LTD. ¿ CAYEY, PR / 00737 D.4 MEDICAL DEVICE CATALOG #: 333184 D.4. MEDICAL DEVICE LOT #: 88591 D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-01-31 D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.5. PMA / 510(K)#: NA G.1 MANUFACTURING LOCATION: BECTON DICKINSON CARIBE LTD. ¿ CAYEY, PR / 00737 H.4. DEVICE MANUFACTURE DATE: 2021-03-29.
H.6. INVESTIGATION: SCOPE OF ISSUE AND PROBLEM STATEMENT: CUSTOMER (AZ SANITARIA PROV VIBO VALENTIA, VIBO VALENTIA) REPORTED THAT PRODUCT 333184 (CD8 FITC/CD38 PE/CD3 PERCP/HLA-DR APC) LOT 88591 HAD HIGH POSITIVITY, HIGHER THAN EXPECTED. CUSTOMER PROVIDED DATA OF RUNS PERFORMED. MANUFACTURING DEFECT TREND: PRODUCT 333184 (CD8 FITC/CD38 PE/CD3 PERCP/HLA-DR APC) LOT 88591 WAS ASSEMBLED IN BDB CAYEY (PLANT 1157) USING MATERIAL SUBASSEMBLY 91-0692PR (MULTITEST CD8/CD38/CD3/HLA-DR), BATCH 1011799 ALSO MANUFACTURED IN BDB CAYEY. MATERIAL 91-0692PR BATCH 1011799 WAS USED TO MANUFACTURE THE FOLLOWING MATERIALS AND CORRESPONDING LOTS: 333184 LOT 88591 ((B)(4) EA); 333184 LOT 25825 ((B)(4) EA). SUBASSEMBLY 91-0692PR BATCH 1011799 WAS MANUFACTURED ACCORDING TO REQUIREMENTS AND MET MANUFACTURING AND QA ACCEPTANCE CRITERIA FOR RELEASE. NO DISCREPANCIES (OOS OR QN) WERE IDENTIFIED IN MANUFACTURING/TESTING BATCH HISTORY RECORD (BHR) OF SUBASSEMBLY 91-0692PR BATCH 1011799 DURING EVALUATED PERIOD OF 15-SEPT-20 TO 15-SEPT-21. ROOT CAUSE ANALYSIS: ROOT CAUSE FOR REPORTED CLAIM IS CUSTOMER RELATED. DATA PROVIDED BY CUSTOMER WAS EVALUATED AND IT WAS FOUND CUSTOMER WAS USING EXPIRED SETUP BEADS, CATALOG NO. 335775 (BD FACS 7-COLOR SETUP BEADS), TO CALIBRATE EQUIPMENT USED TO PERFORM THEIR TESTING. MATERIAL 335775, LOT 85510 WAS USED IN (B)(6) 2021 AND MATERIAL EXPIRATION DATE WAS 31-MAY-21. BASED ON THIS, CUSTOMER DATA PROVIDED USING EXPIRED MATERIALS FOR INSTRUMENT SETUP IS CONSIDERED QUESTIONABLE AND UNSUITABLE FOR ANALYSIS. REFER TO INVESTIGATION SUMMARY FOR DETAILS. COMPLAINT HISTORY REVIEW: ONLY ONE (1) COMPLAINT PR# (B)(4) FOR PRODUCT 333184 (CD8 FITC/CD38 PE/CD3 PERCP/HLA-DR APC) LOT 88591 OR SUBASSEMBLY 91-0692PR (MULTITEST CD8/CD38/CD3/HLA-DR) LOT 1011799 RELATED TO HIGH POSITIVITY, HIGHER THAN EXPECTED, HAVE BEEN REPORTED IN TRACKWISE DURING EVALUATED PERIOD OF (B)(6) 2020 - (B)(6) 2021. IT IS NOTED THERE IS NO ADDITIONAL COMPLAINTS REPORTED AGAINST PRODUCT 333184 LOT 88591 FROM A TOTAL OF (B)(4) EA SOLD TO MARKET. RISK REVIEW: RISK ANALYSIS APPLICABLE FOR PRODUCT 333184 (CD8 FITC/CD38 PE/CD3 PERCP/HLA-DR APC) IS AVAILABLE UNDER FMEA DOCUMENT 333184FMEA ¿MULTITEST CD8/CD38/CD3/HLA-DR¿ (REV. 02). EVALUATION WAS BASED ON INFORMATION HAZARDS, WHICH MIGHT TRIGGER A PROBLEM TO CUSTOMER TO PROPERLY PERFORM TESTING WHILE USING REAGENT. HAZARD(S) IDENTIFIED? YES . REVIEWED ITEM: 1. CONJUGATED ANTIBODY ¿ FINAL PRODUCT FUNCTION: 1. TO DETECT A SPECIFIC CELL SURFACE MARKER. POTENTIAL EFFECTS OF FAILURES: WRONG RESULT-NO MATCHING PROFILE ¿ CUSTOMER INCONVENIENCES ¿ ADDITIONAL TESTING, COST, AND TIME TESTING. DELAY OF TEST RESULTS. POTENTIAL CAUSE OF FAILURE:18. IMPROPER USE OF MATERIAL BY THE USER, AND 19. USE OF EXPIRED MATERIAL BY USER. SEVERITY: 7, OCCURRENCE: 3, DETECTION: 2, RPN: 42, RISK EVALUATION: ACCEPTABLE. RISK CURRENT CONTROLS: LABELING AND CUSTOMER EDUCATION. NEW HAZARD: NONE. MITIGATION(S) ENOUGH : YES. BATCH HISTORY RECORD (BHR) REVIEW: PRODUCT 333184 (CD8 FITC/CD38 PE/CD3 PERCP/HLA-DR APC) LOT 88591 WAS ASSEMBLED IN PLANT 1157 USING MATERIAL SUBASSEMBLY 91-0692PR (MULTITEST CD8/CD38/CD3/HLA-DR) LOT 1011799 MANUFACTURED IN PLANT 1157, WHICH MET ESTABLISHED ACCEPTANCE CRITERIA FOR PRODUCT RELEASE, AS DEMONSTRATED BY EVALUATED BATCH HISTORY RECORD (BHR). MANUFACTURING WAS PERFORMED ACCORDING TO REQUIREMENTS AND MET SPECIFICATIONS WITHOUT ANY DISCREPANCY OR NONCONFORMANCE. RETURNED SAMPLE ANALYSIS: SAMPLES WERE NOT REQUESTED TO BE RETURNED, SINCE QA RETAINS ARE KEPT FOR SUBASSEMBLY 91-0692PR BATCH 1011799, IF NEEDED FOR EVALUATION. RETAIN SAMPLE ANALYSIS: NO RETAIN SAMPLE TESTING DEEMED NECESSARY AT THIS TIME. CUSTOMER PROVIDED DATA WAS EVALUATED. REFER TO INVESTIGATION SUMMARY SECTION FOR DETAILS. INVESTIGATION SUMMARY: CUSTOMER (AZ SANITARIA PROV VIBO VALENTIA, VIBO VALENTIA) REPORTED THAT PRODUCT 333184 (CD8 FITC/CD38 PE/CD3 PERCP/HLA-DR APC) LOT 88591 HAD HIGH POSITIVITY, HIGHER THAN EXPECTED. AS PER PRODUCT INSTRUCTION FOR USE (IFU) 23-8205-05, PRODUCT 333184 (CD8 FITC/CD38 PE/CD3 PERCP/HLA-DR APC) ¿IS INTENDED FOR IN VITRO FLOW CYTOMETRIC IMMUNOPHENOTYPING FOR PERIPHERAL BLOOD LYMPHOCYTES. CD8/CD38/CD3/ANTI-HLA-DR ASSAYS ARE USED IN THE EVALUATION OF ACTIVATED CD8+ T CELLS.¿ DATA PROVIDED BY CUSTOMER WAS EVALUATED AND IT WAS FOUND CUSTOMER WAS USING EXPIRED SETUP BEADS, CATALOG NO. 335775 (BD FACS 7-COLOR SETUP BEADS) TO CALIBRATE EQUIPMENT USED TO PERFORM THEIR TESTING. MATERIAL 335775 LOT 85510 WAS USED IN (B)(6) 2021 AND MATERIAL EXPIRATION DATE WAS 31-MAY-21. TECHNICAL DATA SHEET (TDS) 23-12241-02 FOR CATALOG NO. 335775 (BD FACS 7-COLOR SETUP BEADS), INDICATES: 1. SECTION 4 (REAGENTS), PRECAUTIONS: ¿DO NOT USE BD FACS 7-COLOR SETUP BEADS BEYOND THEIR EXPIRATION DATE OR BEYOND THE DAY-OF-USE STABILITY PERIOD DESCRIBED IN THE STORAGE AND HANDLING SECTION. BEADS USED BEYOND THEIR STABILITY PERIOD BEGIN TO LOSE FLUORESCENCE, RESULTING IN PROGRESSIVELY INACCURATE SETUPS.¿ 2. SECTION 4 (REAGENTS), STORAGE AND HANDLING: ¿STORE THE CONTENTS OF THE KIT AT 2ºC - 8ºC. DO NOT USE AFTER THE EXPIRATION DATE SHOWN ON THE LABEL.¿ 3. SECTION 6 (PROCEDURE), RUNNING CYTOMETER SETUP: ¿ENTER LOT NUMBER, EXPIRATION DATE, TARGET VALUES, AND SPECTRAL OVERLAP FACTORS INTO THE SOFTWARE.¿ 4. SECTION 9 (TROUBLESHOOTING): ¿IF A PROBLEM STILL PERSISTS, ASSESS THE FOLLOWING POSSIBLE CAUSES. MAKE SURE THE SETUP BEADS HAVE NOT PASSED THE EXPIRATION DATE PRINTED ON THE LABEL.¿ IN ADDITION, INSTRUCTIONS FOR USE (IFU) 23-8205-05 FOR PRODUCT 333184 (CD8 FITC/CD38 PE/CD3 PERCP/HLA-DR APC) INDICATES: 1. PROCEDURE SECTION, FLOW CYTOMETRY ANALYSIS: ¿SET UP THE INSTRUMENT AS RECOMMENDED BY MANUFACTURER.¿ 2. LIMITATIONS SECTION: ¿PROCEDURE USING BD MULTITEST REAGENTS MUST ADHERE TO THE INSTRUCTIONS FOR USE FOR THE SPECIFIC INSTRUMENT, SOFTWARE, AND QUALITY CONTROL PROCEDURES USED BY YOUR LABORATORY.¿ AS CUSTOMER WAS USING EXPIRED MATERIALS FOR INSTRUMENT SETUP PRIOR TO ACQUISITION/ANALYSIS USING PRODUCT 333184 (CD8 FITC/CD38 PE/CD3 PERCP/HLA-DR APC) LOT 88591, RESULTS OBTAINED ARE CONSIDERED QUESTIONABLE AND UNSUITABLE FOR ANALYSIS. EVIDENCE DEMONSTRATES MANUFACTURING PROCESS WAS PERFORMED ACCORDING TO REQUIREMENTS FOR PRODUCT 333184 (CD8 FITC/CD38 PE/CD3 PERCP/HLA-DR APC) LOT 88591 AND SUB-ASSEMBLY 91-0692PR (MULTITEST CD8/CD38/CD3/HLA-DR) LOT 1011799, MET RELEASE SPECIFICATIONS WITHOUT DISCREPANCY AND LATER USED SATISFACTORILY AS REFERENCE LOT UNDER 91-0692PR BATCH 1011799 FOR QC RELEASE TEST OF NEWER SUBASSEMBLY 91-0692PR BATCH 1075825. BASED ON INVESTIGATION FINDINGS INCLUDING EVALUATION OF CUSTOMER PROVIDED DATA, NO ADDITIONAL CLAIMS REPORTED AGAINST PRODUCT 333184 (CD8 FITC/CD38 PE/CD3 PERCP/HLA-DR APC) LOT 88591 OR SUBASSEMBLY 91-0692PR (MULTITEST CD8/CD38/CD3/HLA-DR) LOT 1011799, AND EVIDENCE OF NO DISCREPANCIES FOUND ON EVALUATED BHR, THIS CLAIM IS NOT CONFIRMED, AND NO FURTHER ACTIONS ARE DEEMED NECESSARY AT THIS TIME. CONCLUSION: PRODUCT 333184 (CD8 FITC/CD38 PE/CD3 PERCP/HLA-DR APC) LOT 88591 MANUFACTURED FROM SUBASSEMBLY 91-0692PR (MULTITEST CD8/CD38/CD3/HLA-DR) LOT 1011799, WAS MANUFACTURED, AND COMPLIES WITH BD SPECIFICATIONS. BASED ON INVESTIGATION PERFORMED IT IS DETERMINED CLAIM IS NOT CONFIRMED AND NO FURTHER ACTIONS ARE NECESSARY AT THIS TIME.
IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH BD MULTITEST¿ ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOLLOWING THE LOT CHANGE, THERE IS AN INCREASE IN THE PERCENTAGE OF POSITIVITY IN THE SAMPLES MARKED WITH HLA-DR. THE OTHER RESULTS AS RELIABLE. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO.
IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH BD MULTITEST¿ ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOLLOWING THE LOT CHANGE, THERE IS AN INCREASE IN THE PERCENTAGE OF POSITIVITY IN THE SAMPLES MARKED WITH HLA-DR. THE OTHER RESULTS AS RELIABLE. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO.
MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH BD FACSCANTO¿ II FLOW CYTOMETER ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOLLOWING THE LOT CHANGE, THERE IS AN INCREASE IN THE PERCENTAGE OF POSITIVITY IN THE SAMPLES MARKED WITH HLA-DR. THE OTHER RESULTS AS RELIABLE. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1496212 | BD MULTITEST¿ | COUNTER, DIFFERENTIAL CELL | GKZ | BECTON DICKINSON CARIBE LTD. | 338960 | 88591 | 00382903389605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |