BD MULTITEST¿ 6-COLOR TBNK REAGENT W/BD TRUCOUNT¿ TUBES
Report
- Report Number
- 2916837-2022-00129
- Event Type
- Malfunction
- Date Received
- May 20, 2022
- Date of Event
- May 9, 2022
- Report Date
- February 2, 2023
- Manufacturer
- BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
- Product Code
- GKZ
- UDI-DI
- 00382903371662
- PMA / PMN Number
- K060375
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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. INITIAL REPORTER PHONE#: (B)(6). INITIAL REPORTER FAX#: (B)(6).
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD MULTITEST¿ 6-COLOR TBNK REAGENT W/BD TRUCOUNT¿ TUBES ACQUIRED ERRONEOUS RESULTS ON PATIENT SAMPLES. D.1. MEDICAL DEVICE BRAND NAME: BD MULTITEST¿ 6-COLOR TBNK REAGENT W/BD TRUCOUNT¿ TUBES D.4 MEDICAL DEVICE CATALOG #: 337166. D.4. MEDICAL DEVICE LOT #: 302050 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT. D.4. MEDICAL DEVICE SERIAL #: NA . D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION BASED ON CORRECTED CATALOG#: D.1 MEDICAL DEVICE TYPE: GKZ. D.2. COMMON DEVICE NAME: COUNTER, DIFFERENTIAL CELL . G.5. PMA / 510(K)#: K060375.
H. 6 INVESTIGATION SUMMARY ¿ SCOPE OF ISSUE AND PROBLEM STATEMENT: CUSTOMER (ZENTRUM F. DIAGNOSTIK GMBH, CHEMNITZ, GERMANY) REPORTED ON 13-MAY-22 THAT PRODUCT 337166 (BD MULTITEST 6-COLOR TBNK WITH BD TRUCOUNT TUBES, CE-IVD) LOT 32050 IS GIVING ERRONEOUS RESULTS. CUSTOMERS INDICATE THEY COMPARED WITH 2 DIFFERENT SYSMEX BLOOD COUNT INSTRUMENTS, THE LYMPHOCYTE ABSOLUTE VALUES WERE TOO HIGH ON FACSLYRIC. THEY USED TRUCOUNT LOT 21280 AND 6-COLOR TBNK WITH TRUCOUNT IN FACSUITE CLINICAL SOFTWARE FOR THE MEASUREMENTS. CUSTOMER DID NOT PROVIDE DETAILS OF HOW ANALYSIS WAS PERFORMED FOR COMPARING RESULTS BETWEEN DIFFERENT INSTRUMENTS OR PROVIDED DATA OR SHOWING REPORTED PROBLEM. ¿ MANUFACTURING DEFECT TREND: THERE ARE ZERO (0) QUALITY NOTIFICATIONS (QN) OR NONCONFORMANCE REPORTS WERE FOUND AGAINST PRODUCT 337166 (BD MULTITEST 6-COLOR TBNK WITH BD TRUCOUNT TUBES, CE-IVD) LOT 32050 OR SUBASSEMBLY 91-0717 (BD MULTITEST 6-COLOR TBNK) BATCH 1337521 OR 91-0786 (ABSOLUTE COUNT TUBES) BATCH 21280 CONTAINING COMPONENT 91-0195 (TRUCOUNT ABSOLUTE COUNT BEAD PELLET) BATCH 1144744, FROM EVALUATED TIMEFRAME OF 13-MAY-21 TO 13-MAY-22. ¿ BATCH HISTORY RECORD (BHR) REVIEW: PRODUCT 337166 (BD MULTITEST 6-COLOR TBNK WITH BD TRUCOUNT TUBES, CE-IVD) LOT 32050 WAS ASSEMBLED IN BDB SAN JOSE CA (PLANT 1149), USING SUBASSEMBLY 91-0717 (BD MULTITEST 6-COLOR TBNK) BATCH 1337521 AND 91-0786 (ABSOLUTE COUNT TUBES) BATCH 21280, MANUFACTURED IN BDB CAYEY PR (PLANT 1157). SUBASSEMBLY 91-0717 (BD MULTITEST 6-COLOR TBNK) BATCH 1337521 WAS USED TO MANUFACTURE THE FOLLOWING PRODUCTS (TOTAL OF (B)(4) EA UNITS SOLD TO MARKET TO CURRENT DATE 28-OCT-22): 1. 337166 LOT 32050 ((B)(4) EA): (B)(4) EA SOLD TO MARKET . 2. 662967 LOT 32055 ((B)(4) EA): ALL (B)(4) EA SOLD TO MARKET . 3. 644611 LOT 32049 ((B)(4) EA): (B)(4) EA SOLD TO MARKET. 4. 662995 LOT 22043 ((B)(4) EA): ALL (B)(4) EA SOLD TO MARKET. SUBASSEMBLY 91-0786 (ABSOLUTE COUNT TUBES) BATCH 21280, CONTAINING COMPONENT 91-0195 (TRUCOUNT ABSOLUTE COUNT BEAD PELLET) BATCH 1144744, WAS USED TO MANUFACTURE THE FOLLOWING PRODUCTS (TOTAL OF 17(B)(4) EA SOLD TO MARKET TO CURRENT DATE 28-OCT-22): 1. 340334 BATCH 1321546 ((B)(4) EA): ALL (B)(4) EA SOLD TO MARKET. 2. 340334 BATCH 1350932 ((B)(4) EA): ALL (B)(4) EA SOLD TO MARKET. 3. 340334 BATCH 1348909 ((B)(4) EA): ALL (B)(4) EA SOLD TO MARKET. 4. 663028 BATCH 1348535 ((B)(4) EA): ALL (B)(4) EA SOLD TO MARKET. 5. 342447 BATCH 33201 ((B)(4) EA): ALL (B)(4) EA SOLD TO MARKET. 6. 337166 BATCH 32050 ((B)(4) EA): (B)(4) EA SOLD TO MARKET. 7. 342444 BATCH 59135 ((B)(4) EA): ALL (B)(4) EA SOLD TO MARKET. 8. 338331 BATCH 2066424 ((B)(4) EA): ALL (B)(4) EA SOLD TO MARKET. 9. 662995 BATCH 11555 ((B)(4) EA): ALL (B)(4) EA SOLD TO MARKET. 10. 340498 BATCH 2104015 ((B)(4) EA): ALL (B)(4) EA SOLD TO MARKET. 11. 342446 BATCH 10269 ((B)(4) EA): ALL (B)(4) EA SOLD TO MARKET. 12. 342445 BATCH 10268 ((B)(4) EA): ALL (B)(4) EA SOLD TO MARKET. 13. 333185 BATCH 10271 ((B)(4) EA): ALL (B)(4) EA SOLD TO MARKET QC BHR 91-0717 (BD MULTITEST 6-COLOR TBNK) BATCH 1337521 WAS REVIEWED. MATERIAL MET QC SPECIFICATIONS THRU FLOW CYTOMETRY TESTING OF LYSED WHOLE BLOOD METHOD AGAINST A REFERENCE LOT, TESTED IN BD BIOSCIENCES SAN JOSE CA (PLANT 1149) USING LSR II FLOW CYTOMETER INSTRUMENT (ID# M2739), PRIOR TO RELEASE. SUBASSEMBLY 91-0717 (BD MULTITEST 6-COLOR TBNK) BATCH 1337521 WAS LATER SATISFACTORILY USED AS A REFERENCE LOT DURING ROUTINE QC TESTING OF NEWER SUBASSEMBLY 91-0717 BATCH 2004588, MEETING SPECIFICATIONS WITHOUT DISCREPANCY. ABSOLUTE BEAD COUNT AND FLUORESCENCE WAS TESTED UNDER COMPONENT 91-0195 (TRUCOUNT ABSOLUTE COUNT BEAD PELLET) BATCH 1144744, WITH ACCEPTABLE RESULTS PER BD SPECIFICATIONS. MATERIAL EXPIRES 28-FEB-23. NO DEVICE PROBLEM WAS FOUND. ¿ COMPLAINT HISTORY REVIEW: ONE (1) COMPLAINT REPORTED (PR# (B)(4) FROM ZENTRUM F. DIAGNOSTIK GMBH, CHEMNITZ, GERMANY; AGAINST PRODUCT 337166 (BD MULTITEST 6-COLOR TBNK WITH BD TRUCOUNT TUBES, CE-IVD) LOT 32050 HAVING LYMPHOCYTE ABSOLUTE VALUES TOO HIGH, FROM DATE RANGE OF 13-MAY-21 TO 13-MAY-22. NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED TO DATE FROM A TOTAL OF (B)(4) EA UNITS SOLD TO MARKET OF ANY OF THE FOUR (4) DIFFERENT CATALOG/LOT PRODUCTS MANUFACTURED USING SAME SUBASSEMBLY 91-0717 (BD MULTITEST 6-COLOR TBNK) BATCH 1337521 OR TOTAL OF (B)(4) EA SOLD TO MARKET OF ANY OF THE THIRTEEN (13) DIFFERENT CATALOG/LOT PRODUCTS MANUFACTURED USING SAME SUBASSEMBLY 91-0786 (ABSOLUTE COUNT TUBES) BATCH 21280. ¿ RETAIN SAMPLE ANALYSIS: RELEASE TESTING FOR PRODUCT 337166 (BD MULTITEST 6-COLOR TBNK WITH BD TRUCOUNT TUBES, CE-IVD) LOT 32050 WAS FLOW CYTOMETRY USING PERIPHERAL BLOOD UNDER SUBASSEMBLY 91-0717 BATCH 1337521, AGAINST A REFERENCE LOT, VISUAL INSPECTION OF ASSEMBLED TRUCOUNT TUBES 91-0786 BATCH 21280 AND BEAD COUNTING OF 91-0195 BATCH 1144744. THE ACCEPTANCE CRITERIA FOR RELEASE WERE MET: CD3 FITC (CD3+, TOTAL T CELLS) PERCENT POSITIVE: +/- 4% OF REFERENCE. TEST BATCH 1337521 RESULT: 0.3%. CD3 FITC (CD3+, TOTAL T CELLS) MFI: >/= 3,000. TEST BATCH 1337521 RESULT: 4,666. CD16+CD56+ PE (CD19-/CD16+/CD56+, NK CELLS) PERCENT POSITIVE: +/- 3% OF REFERENCE. TEST BATCH 1337521 RESULT: -1.4%. CD16+CD56+ PE (CD19-/CD16+/CD56+, NK CELLS) MFI: >/= 5,000. TEST BATCH 1337521 RESULT: 10,570. CD19 APC (CD19+/CD16-/CD56-, B CELLS) PERCENT POSITIVE: +/- 3% OF REFERENCE. TEST BATCH 1337521 RESULT: 1.1%. CD19 APC (CD19+/CD16-/CD56-, B CELLS) MFI: >/= 2,400. TEST BATCH 1337521 RESULT: 3,421. CD4 PE-CY7 (CD8-/CD4+, T HELPER CELLS) PERCENT POSITIVE: +/- 4% OF REFERENCE. TEST BATCH 1337521 RESULT: 0.1%. CD4 PE-CY7 (CD8-/CD4+, T HELPER CELLS) MFI: >/= 3,000. TEST BATCH 1337521 RESULT: 6,874. CD8 APC-CY7 (CD8+/CD4-, T CYTOTOXIC CELLS) PERCENT POSITIVE: +/- 3% OF REFERENCE. TEST BATCH 1337521 RESULT: 0.2%. CD8 APC-CY7 (CD8+/CD4-, T CYTOTOXIC CELLS) MFI: >/= 5,000. TEST BATCH 1337521 RESULT: 12,742. ADDITIONALLY, RETAIN SAMPLE OF PRODUCT 337166 (BD MULTITEST 6-COLOR TBNK WITH BD TRUCOUNT TUBES, CE-IVD) LOT 32050 WAS TESTED USING BD MULTI-CHECK CONTROL, WHICH CONTAINS WHOLE BLOOD FOR LYMPHOCYTE SUBSET ENUMERATION WITH CHARACTERIZED RANGES OF CD3+, CD3+/CD4+, CD3+/CD8+, CD19+, CD3-/CD16+CD56+, CD3+/HLA-DR+, AND CD45+/CD14- SUBSET LYMPHOCYTE POPULATIONS. DATA OBTAINED FROM FIVE (5) STAINING REPLICATES IS SUMMARIZED ON ATTACHED RETAIN 337166-32050_TEST DATA SUMMARY FILE, WHICH CONFIRMS PRODUCT 337166 (BD MULTITEST 6-COLOR TBNK WITH BD TRUCOUNT TUBES, CE-IVD) LOT 32050 PERFORMS AS INTENDED. DATA FROM EACH OF THE FIVE (5) REPLICATE SAMPLES SHOWS THE ASSIGNED SUBSET POPULATION PERCENT AND ABSOLUTE COUNT VALUES WERE WITHIN SPECIFICATION EXPECTED RANGES FOR ALL PREVIOUSLY DEFINED POSITIVE SUBSET POPULATIONS, USING BD MULTI-CHECK CONTROL BATCH BM1122N (EXP. DATE 02-DEC-22). ¿ RETURNED SAMPLE ANALYSIS: AS NO DATA OR DETAILS PROVIDED BY CUSTOMER REGARDING REPORTED PROBLEM, WFI TASK PR# (B)(4) REQUESTED FOR FURTHER CUSTOMER INFORMATION. REFER TO ROOT-CAUSE ANALYSIS SECTION FOR DETAILS. ¿ RISK REVIEW: (PERFORM 1 RISK ANALYSIS FOR EACH HAZARD IDENTIFIED) RISK MANAGEMENT FILE (B)(4), REVISION 07 WAS REVIEWED. HAZARD(S) IDENTIFIED? X YES / NO. IF NO (TO ABOVE), WHAT ACTIONS WILL BE TAKEN? ¿ HAZARD ID#: 4.1. ¿ HAZARD: INFORMATION HAZARD. ¿ CAUSE: INADEQUATE INSTRUCTIONS PROVIDED BY BD. ¿ HARMFUL EFFECTS: UNABLE TO PERFORM TESTING, DELAY OF TEST RESULTS. ¿ PROBABILITY: 1. ¿ SEVERITY: 3. ¿ RISK INDEX: 3 = ACCEPTABLE. ¿ IMPLEMENTATION: IFU . ¿ NEW HAZARD: NONE. MITIGATION(S) SUFFICIENT X YES / NO. IF NO (TO ABOVE), WHAT ACTIONS WILL BE TAKEN? ¿ ROOT CAUSE ANALYSIS: WFI TASK PR# (B)(4) REQUESTED INFORMATION AND CUSTOMER RESPONSE TO SUPPORT INVESTIGATION: 1. DESCRIBE STEP-BY-STEP PROCESS FOLLOW FOR STAINING, FLOW CYTOMETRY ACQUISITION AND ANALYSIS USING PRODUCT 337166 (BD MULTITEST 6-COLOR TBNK W TRUCOUNT) LOT 32050. A. INDICATE WHICH TYPE OF PATIENT OR CONTROL SAMPLES WERE USED FOR STAINING/ANALYSIS? I. WHERE CELLS PREVIOUSLY FIXED OR STORED SAMPLES? II. WHERE SAME SAMPLES USED FOR COMPARISON ACROSS DIFFERENT INSTRUMENTS? B. INDICATE HOW MUCH VOLUME (L) OF 337166 (BD MULTITEST 6-COLOR TBNK W TRUCOUNT) LOT 32050 REAGENT WAS USED FOR STAINING SAMPLES. C. PROVIDE IMAGE OF FLOW CYTOMETRY DATA SHOWING RESULTS. CUSTOMERS RESPONSE: ACCORDING THE IFU FOR 6-COLOR TBNK REAGENT. A. PERIPHERAL BLOOD AND BD MULTITEST CONTROLS CD4 LOW AND NORMAL. I. NO FIXATION, SAMPLES MAXIMUM 24H STORED AT ROOM TEMPERATURE. II. YES. B. 20 L ACCORDING THE IFU. C. NO DATA PROVIDED BY CUSTOMER. 2. DESCRIBE HOW WAS COMPARISON BETWEEN BD FACSLYRIC AND COULTER SYSMEX COUNTER DONE, INCLUDING REAGENTS USED, SAMPLES STAINED, AND ACTUAL RESULTS OBTAINED ON EACH. A. HOW IS PRODUCT 337166 (BD MULTITEST 6-COLOR TBNK W TRUCOUNT) LOT 32050 BEING COMPARED BETWEEN FACSLYRIC AND SYSMEX INSTRUMENTS? I. ARE YOU USING DIFFERENT REAGENTS/PRODUCTS AND COUNTING TUBES FOR EACH INSTRUMENT (BD FACSLYRIC VS SYSMEX) PLATFORMS? IF SO, PLEASE SPECIFY PRODUCT CATALOG NUMBERS. II. ARE YOU USING SAME PRODUCT 337166 (BD MULTITEST 6-COLOR TBNK W TRUCOUNT) LOT 32050 IN BOTH FACSLYRIC AND SYSMEX INSTRUMENTS? B. INDICATE HOW THE ABSOLUTE NUMBER OF GATED CELLS WAS DETERMINED? MANUALLY OR USING THE BD SOFTWARE? C. INDICATE EXACT BEAD COUNT NUMBER USED FOR ANALYSIS USING BD TRUCOUNT TUBES USING PRODUCT 337166 LOT 32050. HOW WAS THIS BEAD COUNT NUMBER USED ON FACSUITE CLINICAL SOFTWARE FOR ABSOLUTE COUNTING? I. HOW WAS COUNTING PERFORMED ACROSS FACSLYRIC AND SYSMEX INSTRUMENTS? CUSTOMERS RESPONSE: NO DETAILED INFORMATION OR DATA PROVIDED BY CUSTOMER OF HOW WAS COUNTING PERFORMED OR EXACT BEAD COUNT USED FOR CALCULATION WHILE USING BD TRUCOUNT TUBES, WHICH IS KNOWN TO BE CRITICAL FOR PRECISE CELL COUNTING. CUSTOMER STATED THE BD TRUCOUNT TUBES WERE USED ON BD FACSLYRIC WHILE THE SYSMEX IS A BLOOD COUNTER, WHICH DOES NOT USE BD REAGENTS OR COUNTING TUBES. 3. WHEN USING TRUCOUNT TUBES FOR COUNTING, APPROXIMATELY HOW LONG (TIME IN HOURS) WERE TUBES MAINTAINED OUT OF POUCH PRIOR USE? APPROXIMATELY HOW LONG (IN HOURS/DAYS) WERE TRUCOUNT TUBE POUCHES OPEN SINCE FIRST OPEN FOR USE AND LATER USE FOR THIS ANALYSIS? CUSTOMERS RESPONSE: NO DETAILED INFORMATION PROVIDED BY CUSTOMER OF HOW LONG BD TRUCOUNT TUBES WERE MAINTAINED OUT OF POUCH AFTER OPENING TO PRESERVE FUNCTIONALITY, AS DESCRIBED ON IFU 23-10834-08, STORAGE AND HANDLING SECTION. 4. HAVE YOU RECEIVED TECHNICAL GUIDANCE FROM BD BIOSCIENCES REGARDING PRODUCT 337166 (BD MULTITEST 6-COLOR TBNK W TRUCOUNT) LOT 32050 USE, OPTIMAL REAGENT VOLUME FOR STAINING AND HOW TO PERFORM TROUBLESHOOTING FOR REPORTED PROBLEM? CUSTOMERS RESPONSE: CUSTOMERS INDICATE YES. COMPLAINT HISTORY REVEALS NO ADDITIONAL RELATED COMPLAINTS AGAINST PRODUCT 337166 (BD MULTITEST 6-COLOR TBNK WITH BD TRUCOUNT TUBES, CE-IVD) LOT 32050 OR ANY OF THE FOUR (4) PRODUCTS/LOTS MANUFACTURED USING SAME SUBASSEMBLY 91-0717 (BD MULTITEST 6-COLOR TBNK) BATCH 1337521 OF WHICH A TOTAL (B)(4) EA UNITS HAVE BEEN SOLD TO MARKET, OR ANY OF THE THIRTEEN (13) PRODUCTS/LOTS MANUFACTURED USING SAME SUBASSEMBLY 91-0786 (ABSOLUTE COUNT TUBES) BATCH 21280 OF WHICH A TOTAL OF (B)(4) EA HAVE BEEN SOLD TO MARKET TO CURRENT DATE. BASED ON INVESTIGATION FINDINGS, INCLUDING EVALUATED BHR FLOW CYTOMETRY DATA AND RETAIN TEST RESULTS WHICH CONFIRM PRODUCT PERFORMS AS INTENDED, ROOT-CAUSE FOR REPORTED INCIDENT CANNOT BE DETERMINED. ¿ CONCLUSION: BASED ON THIS INVESTIGATION FOR PRODUCT 337166 (BD MULTITEST 6-COLOR TBNK WITH BD TRUCOUNT TUBES, CE-IVD) LOT 32050, THIS COMPLAINT IS UNCONFIRMED, AND NO FURTHER ACTIONS DEEMED NECESSARY AT THIS TIME.
IT WAS REPORTED THAT BD FACSLYRIC¿ ACQUIRED ERRONEOUS RESULTS ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "COMPARED WITH 2 DIFFERENT SYSMEX BLOOD COUNT INSTRUMENTS, THE LYMPHOCYTE ABSOLUTE VALUES WERE TOO HIGH ON FACSLYRIC. THEY USED TRUCOUNT LOT 21280 AND 6CTBNK+TRUC IN FACSUITE CLINICAL SOFTWARE FOR THE MEASUREMENTS. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, GO TO QUESTION #2, IF NO, NO FURTHER QUESTIONS REQUIRED.) YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3) NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4) NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED) NO."
IT WAS REPORTED THAT THE BD MULTITEST¿ 6-COLOR TBNK REAGENT W/BD TRUCOUNT¿ TUBES ACQUIRED ERRONEOUS RESULTS ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "COMPARED WITH 2 DIFFERENT SYSMEX BLOOD COUNT INSTRUMENTS, THE LYMPHOCYTE ABSOLUTE VALUES WERE TOO HIGH ON FACSLYRIC. THEY USED TRUCOUNT LOT 21280 AND 6CTBNK+TRUC IN FACSUITE CLINICAL SOFTWARE FOR THE MEASUREMENTS. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, GO TO QUESTION #2, IF NO, NO FURTHER QUESTIONS REQUIRED.) YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3) NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4). NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED) NO".
IT WAS REPORTED THAT BD FACSLYRIC¿ ACQUIRED ERRONEOUS RESULTS ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "COMPARED WITH 2 DIFFERENT SYSMEX BLOOD COUNT INSTRUMENTS, THE LYMPHOCYTE ABSOLUTE VALUES WERE TOO HIGH ON FACSLYRIC. THEY USED TRUCOUNT LOT 21280 AND 6CTBNK+TRUC IN FACSUITE CLINICAL SOFTWARE FOR THE MEASUREMENTS. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, GO TO QUESTION #2, IF NO, NO FURTHER QUESTIONS REQUIRED.) YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3) NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4) NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED) NO".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1004498 | BD MULTITEST¿ 6-COLOR TBNK REAGENT W/BD TRUCOUNT¿ TUBES | COUNTER, DIFFERENTIAL CELL | GKZ | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES | 337166 | 302050 | 00382903371662 |
| 2441593 | BD MULTITEST¿ 6-COLOR TBNK REAGENT W/BD TRUCOUNT¿ TUBES | COUNTER, DIFFERENTIAL CELL | GKZ | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES | 337166 | 302050 | 00382903371662 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |