BD TRUCOUNT TUBES
Report
- Report Number
- 2647876-2021-00005
- Event Type
- Malfunction
- Date Received
- June 21, 2021
- Date of Event
- May 24, 2021
- Report Date
- August 16, 2021
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- GKZ
- UDI-DI
- 00382903403349
- PMA / PMN Number
- K970836
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H6: INVESTIGATION SUMMARY: INCLUDE ALL ELEMENTS UNDER THE INVESTIGATION SUMMARY. UPON COMPLETION, REFER TO INVESTIGATION SUMMARY. ¿ OTHER INVESTIGATION ANALYSIS: O SCOPE OF ISSUE AND PROBLEM STATEMENT: CUSTOMER (CLINICA DE LA SALUD INTEGRAL, GUATEMALA) REPORTED COMPLAINT ON PRODUCT 340334 (TRUCOUNT ABSOLUTE COUNTING TUBES, IVD) LOT 9224566 ON 25/MAY/2021. THE CLAIM ESTABLISHED ¿PEARL MEASUREMENT PROBLEMS¿ REPORTING AN ERRONEOUS RESULT NEEDING TO REPEAT 9 SAMPLES FROM A TOTAL OF 40 SAMPLES RUN. O MANUFACTURING DEFECT TREND: PRODUCT 340334 (TRUCOUNT ABSOLUTE COUNTING TUBES, IVD) LOT 9224566 WAS ASSEMBLED IN BDB SAN JOSE CA (PLANT 1149), USING POUCHED SUBASSEMBLY 91-0786 (POUCHED ABSOLUTE COUNT TUBES) BATCH 19171 MANUFACTURED IN BDB CAYEY (PLANT 1157) AND USING TRUCOUNT ABSOLUTE COUNT PELLET SUBASSEMBLY 91-0195 BATCH 8109647 MANUFACTURED IN BDB SAN JOSE CA (PLANT 1149). ZERO (0) NON-CONFORMANCE (QN) REPORT OR DISCREPANCY WAS FOUND OR REPORTED IN EVALUATED BHR RECORD FOR SUBASSEMBLY 91-0786 (POUCHED ABSOLUTE COUNT TUBES) BATCH 19171 AND ITS COMPONENT SUBASSEMBLY 91-0195 (TRUCOUNT ABSOLUTE COUNT PELLET) LOT 8109647, DURING EVALUATED PERIOD OF 25-MAY-2020 TO 25-MAY-2021. O ROOT CAUSE ANALYSIS: ACCORDING TO RISK ANALYSIS "BD TRUCOUNT TUBES RISK ANALYSIS" 10000490283, REVISION 2, THE ERRONEOUS/INACCURATE RESULTS OBSERVED BY THE CUSTOMER COULD BE RELATED TO MULTIPLE FACTORS: (1) IMPROPER USE ADDING THE INCORRECT SAMPLE VOLUME. TECHNICAL DATA SHEET (TDS) OR IFU (INSTRUCTIONS FOR USE) FOR MATERIAL 340334 (DOCUMENT NUMBER 23-22402-01), PROVIDES CLEAR INSTRUCTION OF HOW CRITICAL IT IS TO ACCURATELY PIPETTE 50UL OF SAMPLE INTO THE TUBE. IFU INDICATES THAT THE ADDITION OF A PRECISE VOLUME OF BLOOD IS CRITICAL TO ACHIEVING THE RESULT. THE PIPETTES MUST BE CALIBRATED TO DELIVER EXACTLY QUANTITY OF SAMPLE, THEREFORE THE IFU RECOMMEND USING A BD ELECTRONIC PIPETTE OR USE THE REVERSE PIPETTING TECHNIQUE TO PIPETTE SAMPLE ONTO THE SIDE OF THE TUBE JUST ABOVE THE RETAINER. IT IS ACKNOWLEDGED THAT CUSTOMER DOES NOT PROVIDE SPECIFIC DETAILS ABOUT HOW THE TESTING AND SAMPLE PREPARATION WERE HANDLED. (2) THE NUMBER OF BEADS IN THE PELLET VARY FROM TUBE TO TUBE PROVIDING INACCURATE RESULTS. AS A RISK CONTROL THE TRUCOUNT TUBES ARE DESIGNED IN A WAY TO PREVENT LARGE TUBE TO TUBE VARIATION, AND THE ACCEPTANCE CRITERIA FOR THE BEAD PELLETS IS TIGHT ENOUGH (SPEC OVERALL %CV = 3.5%) TO PREVENT THE NUMBER OF BEADS PELLET TO VARY GREATLY FROM TUBE TO TUBE. AS PER THE BHR EVALUATION, THE PELLET RAW MATERIAL 91-0195 BATCH 8109647 MET ALL THE ACCEPTANCE CRITERIA PRIOR TO RELEASE, PROVIDING A BEAD COUNT OF 50,400 (SPEC BEADS/PELLET: RANGE 45,000 ¿ 55,000) AND AN OVERALL %CV OF 2.28 (SPEC OVERALL %CV = 3.5%). RAW MATERIAL COMPONENT BEAD PELLET 91-0195 BATCH 8109647 WENT THRU INCOMING QA INSPECTION IN BDB CAYEY (PLANT 1157) AND MET BD SPECIFICATIONS WITHOUT DISCREPANCIES OR QUALITY NOTIFICATIONS (QNS). (3) USER ENTERS BEAD COUNT NUMBER INCORRECTLY RESULTING IN INCORRECT WBC ABSOLUTE COUNT PROVIDING INACCURATE RESULTS. IFU PROVIDES CLEAR INSTRUCTIONS THAT ALWAYS BE SURE TO USE THE BEAD COUNT FROM THE CURRENT LOT OF BD TRUCOUNT TUBES WHEN ENTERING THIS VALUE IN THE SOFTWARE. THE CORRECT BEAD COUNT IS CRITICAL FOR DETERMINING A CELL COUNT. ALSO, IFU INSTRUCTS TO DO NOT MIX MULTIPLE LOTS OF TUBES IN THE SAME ASSAY. IT IS ACKNOWLEDGED THAT CUSTOMER DOES NOT PROVIDE SPECIFIC DETAILS ABOUT HOW THE TESTING WAS HANDLED, THE BEAD COUNT NUMBER ENTERED OR IF MORE THAN ONE BATCH WAS USED IN THE SAME ASSAY. (4) PRODUCT DEGRADES FASTER THAN EXPECTED BECAUSE THE USER OPENS THE POUCH PRIOR TO THE POUCH REACHING RT PROVIDING INACCURATE RESULTS. IFU PROVIDES CLEAR INSTRUCTION OF WAITING FOR THE POUCH TO REACH RT TO AVOID POTENTIAL CONDENSATION AND CAREFULLY RESEAL THE POUCH IMMEDIATELY AFTER REMOVING A TUBE. ALSO, IFU INSTRUCTS TO USE THE TUBES WITHIN 1 HOUR AFTER REMOVAL FROM THE FOIL POUCH. IT IS ACKNOWLEDGED THAT CUSTOMER DOES NOT PROVIDE SPECIFIC DETAILS ABOUT HOW THE TESTING AND SAMPLE PREPARATION WERE HANDLED AND IF THE TUBES WERE EXPOSED FOR MORE THAN ONE HOUR AFTER REMOVAL FROM THE FOIL POUCH. EXPOSURE OF THE LYOPHILIZED PELLET TO HUMIDITY AND MOISTURE COULD RESULT IN THE PELLET DISSOCIATING IN THE WATER GAINED. PER THE FMEA, UNDER THE MANUFACTURING PROCESS, EXPOSURE OF HUMIDITY COULD RESULT FROM PERFORMING THE ASSEMBLY PROCESS WITHOUT HUMIDITY CONTROLS, HAVING AN INEFFICIENT POUCH SEALING, OR HAVING A DISRUPTION TO THE SEALED POUCH DURING PACKING. ALSO, A POUCH SEAL COULD BE DISRUPTED DURING STORAGE OR SHIPPING DUE TO AN EXTERNAL SOURCE. THE CONTROLS ESTABLISHED PER FMEA WERE EVALUATED AND THE FINDINGS SUPPORT THAT THE MATERIAL 91-0786 BATCH 19171 COMPLIED WITH ALL BDB REQUIREMENTS ESTABLISHED. THE MANUFACTURING ROOM WAS UNDER CONTROL FOR RELATIVE HUMIDITY (=10%), THE ASSEMBLED TUBE 100% INSPECTION HAD NO ALERT OR ACTIONS REPORTED AND PASS AQL INSPECTION, THE POUCH SEALING VALIDATED PROCESS PASSED 100% INSPECTION AND AQL INSPECTION, THE MATERIAL 91-0786 BATCH 19171 WAS PACKED ACCORDINGLY AND SHIPPED FROM CAYEY TO SAN JOSE WITHOUT ANY NONCONFORMANCE OR DISCREPANCY REPORTED. THUS, THE ASSEMBLY PROCESS OF MATERIAL 91-0786 BATCH 19171OCCURRED UNDER ESTABLISHED CONTROLS, WITHOUT DISCREPANCIES OR DEVIATIONS. ACCORDING TO FMEA-TRUC-18030 REV. 4, THE DEFECT OF INACCURATE RESULTS OBSERVED BY THE CUSTOMER COULD BE RELATED TO MULTIPLE FACTORS: (1) PELLET NOT UNDER RETAINER PROVIDING INACCURATE RESULTS OR (2) MULTIPLE PELLET/PELLET FRAGMENT OR CRUSHED PROVIDING INACCURATE RESULTS. AUTOMATIC MACHINE VISION SYSTEM DETECT SMALL PELLETS OVER RETAINER, MULTIPLE PELLETS OR PELLET FRAGMENT OR CRUSHED IN ADDITION A 100% VISUAL INSPECTION IS PERFORMED TO DETECT THESE DEFECTS. ACTION AND ALERT LIMITS MONITORED DAILY PER MF0183-PR-04 FOR 100% VISUAL INSPECTION DETECTION RESULTS. THE CONTROLS ESTABLISHED PER FMEA WERE EVALUATED AND THE FINDINGS SUPPORT THAT THE MATERIAL 91-0786 BATCH 19171 COMPLIED WITH ALL BDB REQUIREMENTS ESTABLISHED. IN ADDITION, IFU CLEARLY INDICATES TO DISCARD TUBE IF NOT INTACT AND TO USE TUBE WITHIN ONE HOUR AFTER REMOVAL FROM THE FOIL POUCH. BASED ON THE INVESTIGATION RESULT, ROOT CAUSE CANNOT BE DETERMINED. BUT INVESTIGATION SHOWS THAT THERE IS NO EVIDENCE OF PHYSICAL DEFECTS RELATED TO THE SUBASSEMBLY PROCESS OF 91-0786 (POUCHED ABSOLUTE COUNT TUBES) BATCH 19171 MANUFACTURED IN BDB CAYEY (PLANT 1157). ¿ COMPLAINT HISTORY REVIEW: THE MATERIAL 91-0786 BATCH 19171, WAS FURTHER USED IN 9 LOTS OF 3 DIFFERENT TRUCOUNT RELATED KITS. THESE KITS WERE 340334 (TRUCOUNT ABSOLUTE COUNTING TUBES, IVD), 342447 (CD3 FITC/CD8 PE/CD45 PERCP/CD4 APC WITH BD TRUCOUNT¿ TUBES) AND 333185 (CD8 FITC/CD38 PE/CD3 PERCP/ANTI-HLA-DR APC WITH BD TRUCOUNT¿ TUBES). THERE WERE NO COMPLAINTS ASSOCIATED TO ANY OF THESE 9 LOTS RELATED TO ERRONEOUS RESULTS AS EVALUATED IN THE TRACKWISE SYSTEM FOR THE PERIOD OF 25-MAY-2020 TO 25-MAY-2021. THERE IS ONE ADDITIONAL COMPLAINT (PR2964389) RELATED TO THE REPORTED PRODUCT 340334 BATCH 9224566 AS EVALUATED IN THE TRACKWISE SYSTEM, BUT THIS COMPLAINT IS RELATED TO THE SIZE OF THE PELLET AND PELLET OVER THE RETAINER, WHICH USED MATERIAL 91-0786 BATCH 19171. THE INVESTIGATION OF THIS COMPLAINT DID NOT CONFIRM THE CLAIM AS RELATED TO THE ASSEMBLY PROCESS. O RELATED COMPLAINT(S): THIS COMPLAINT PR2970899, FOR PRODUCT 340334 BATCH 9224566, SUBASSEMBLY MATERIAL 91-0786 BATCH 19171, AND PR2964389, FOR PRODUCT 340334 BATCH 9224566, SUBASSEMBLY MATERIAL 91-0786 BATCH 19171 FOR THE CLAIM OF SMALL PELLET, WHICH ACCORDING TO INVESTIGATION ARE UNCONFIRMED TO BE RELATED TO MANUFACTURING PROCESS. ¿ RISK REVIEW: RISK ANALYSIS FOR REPORTED CLAIM WAS PERFORMED BY REVIEWING "BD TRUCOUNT TUBES RISK ANALYSIS" 10000490283, REVISION 2. 1. HAZARD(S) IDENTIFIED? X YES ¿NO HAZARD, INDICATES CAUSE OF: 1) ¿IMPROPER USE: INCORRECT SAMPLE VOLUME¿ PROVIDING INACCURATE RESULTS. SEVERITY: 3 PROBABILITY: 1 RISK INDEX: 3 IMPLEMENTATION: 1) IFU, SECTION 3 AND SECTION 6 RISK CONTROL: (1) IFU PROVIDES CLEAR INSTRUCTION OF HOW CRITICAL IT IS TO ACCURATELY PIPETTE 50UL OF SAMPLE INTO THE TUBE. (2) CUSTOMER EDUCATION. COMMENT: DETECTION IS HIGH, CONTROLS ARE IN PLACE). NEW HAZARD: NONE MITIGATION(S) ENOUGH: X YES ¿NO 2. HAZARD(S) IDENTIFIED? X YES ¿NO HAZARD, INDICATES CAUSE OF: 1) ¿THE NUMBER OF BEADS IN THE PELLET VARY FROM TUBE TO TUBE¿ PROVIDING INACCURATE RESULTS. SEVERITY: 3 PROBABILITY: 1 RISK INDEX: 3 IMPLEMENTATION: 1) MS91-0195, 2) QC91-0195 RISK CONTROL: THE TRUCOUNT TUBES ARE DESIGNED IN A WAY TO PREVENT LARGE TUBE TO TUBE VARIATION, AND THE ACCEPTANCE CRITERIA FOR THE BEAD PELLETS IS TIGHT ENOUGH TO PREVENT THE NUMBER OF BEADS PELLET TO VARY GREATLY FROM TUBE TO TUBE. COMMENT: DETECTION IS HIGH, CONTROLS ARE IN PLACE). NEW HAZARD: NONE MITIGATION(S) ENOUGH: X YES ¿NO 3. HAZARD(S) IDENTIFIED? X YES ¿NO HAZARD, INDICATES CAUSE OF: 1) ¿USER ENTERS BEAD COUNT NUMBER INCORRECTLY RESULTING IN INCORRECT WBC ABSOLUTE COUNT¿ PROVIDING INACCURATE RESULTS. SEVERITY: 3 PROBABILITY: 1 RISK INDEX: 3 IMPLEMENTATION: 1) TECHNICAL DATA SHEET, 2) BD CUSTOMER EDUCATION RISK CONTROL: 1) TECHNICAL SERVICE SUPPORT 2) POUCH FOIL LABEL WITH LOT NUMBER AND BEAD COUNT 3) INSTRUCTIONS FOR USE COMMENT: DETECTION IS HIGH, CONTROLS ARE IN PLACE). NEW HAZARD: NONE MITIGATION(S) ENOUGH: X YES ¿NO 4. HAZARD(S) IDENTIFIED? X YES ¿NO HAZARD, INDICATES CAUSE OF: 1) ¿PRODUCT DEGRADES FASTER THAN EXPECTED BECAUSE THE USER OPENS THE POUCH PRIOR TO THE POUCH REACHING RT¿ PROVIDING INACCURATE RESULTS. SEVERITY: 3 PROBABILITY: 1 RISK INDEX: 3 IMPLEMENTATION: 1) PRODUCT IFU CONTAINS PROPER INSTRUCTIONS RISK CONTROL: 1) WARNING IN IFU 2) CUSTOMER EDUCATION 3) ENGINEERING STUDY 4) DATA IN DEVELOPMENT REPORT COMMENT: DETECTION IS HIGH, CONTROLS ARE IN PLACE). NEW HAZARD: NONE MITIGATION(S) ENOUGH: X YES ¿NO RISK ANALYSIS FOR REPORTED CLAIM WAS ALSO PERFORMED BY REVIEWING "FAILURE MODE AND EFFECT ANALYSIS (FMEA) FOR THE TRUCOUNT TUBE ASSEMBLY PROCESS" FMEA-TRUC-18030 REVISION 4. 1. HAZARD(S) IDENTIFIED? X YES ¿NO HAZARD, INDICATES CAUSE OF ¿PELLET NOT UNDER RETAINER¿ PROVIDING INACCURATE RESULTS SEVERITY: 7 PROBABILITY: 1 RISK INDEX: 7, MODERATE IMPLEMENTATION: 1) CONTROLLED ROOM FOR RH (<10%; AHU 107) 2) SET UP OF STATION 3 DEFINED IN MF0183-PR AND MF0206-PR, 3) THERE IS ESTABLISHED PELLET INCOMING MATERIAL INSPECTION (91-0195RMS-PR) 4) AUTOMATIC MACHINE VISION SYSTEM DETECT SMALL PELLETS OVER RETAINER, 5) 100% VISUAL INSPECTION DETECT SMALL PELLETS OVER RETAINER, RISK CONTROL: 1) ACTION AND ALERT LIMITS MONITORED DAILY PER MF0183-PR-04 FOR 100% VISUAL INSPECTION DETECTION RESULTS, 2) QA0024-PR-04 DEFINES AQL INSPECTION PLAN. 3) IFU, TDS INDICATES TO DISCARD TUBE IF NOT INTACT. 4) IFU, TDS INDICATES TO USE TUBE WITHIN ONE HOUR AFTER REMOVAL FROM THE FOIL POUCH. 5) IFU, FOIL POUCH LABEL 23-3823-08 INDICATES TO USE TUBE WITHIN 1 MONTH AFTER OPENING OF THE POUCH. COMMENT: DETECTION IS HIGH, CONTROLS ARE IN PLACE, THUS RPN IS LOW (7, <125). NEW HAZARD: NONE MITIGATION(S) ENOUGH: X YES ¿NO 2. HAZARD(S) IDENTIFIED? X YES ¿NO HAZARD, INDICATES CAUSE OF ¿MULTIPLE PELLET/PELLET FRAGMENT OR CRUSHED¿ PROVIDING INACCURATE RESULTS SEVERITY: 7 PROBABILITY: 1 RISK INDEX: 7, MODERATE IMPLEMENTATION: 1) CONTROLLED ROOM FOR RH (<10%; AHU 107) 2) SET UP OF STATION 3 DEFINED IN MF0183-PR AND MF0206-PR, 3) THERE IS ESTABLISHED PELLET INCOMING MATERIAL INSPECTION (91-0195RMS-PR) 4) AUTOMATIC MACHINE VISION SYSTEM DETECT CRUSHED PELLET AND REJECT DEFECTIVE UNIT, 5) PM-CLEANING OF THE PELLET BOWL FEEDER AS PER MF0183-PR-01 RISK CONTROL: 1) ACTION AND ALERT LIMITS MONITORED DAILY PER MF0183-PR-04 FOR 100% VISUAL INSPECTION DETECTION RESULTS, 2) QA0024-PR-04 DEFINES AQL INSPECTION PLAN. 3) IFU, TDS INDICATES TO DISCARD TUBE IF NOT INTACT. 4) IFU, TDS INDICATES TO USE TUBE WITHIN ONE HOUR AFTER REMOVAL FROM THE FOIL POUCH. 5) IFU, FOIL POUCH LABEL 23-3823-08 INDICATES TO USE TUBE WITHIN 1 MONTH AFTER OPENING OF THE POUCH. COMMENT: DETECTION IS HIGH, CONTROLS ARE IN PLACE, THUS RPN IS LOW (7, <125). NEW HAZARD: NONE MITIGATION(S) ENOUGH: X YES ¿NO ¿ BATCH HISTORY RECORD (BHR) REVIEW: MATERIAL 340334 BATCH 9224566 WAS MANUFACTURED IN PLANT 1149 USING THE SUBASSEMBLY MATERIAL 91-0786 BATCH 19171 MANUFACTURED IN PLANT 1157. BHR PART 91-0786 BATCH 19171 (PKG0003-PR POUCHED TUBE INSPECTION POINT RELEASE) WAS REVIEWED. THE MATERIAL MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THERE WERE 36,161EA (ASSEMBLED POUCHES) MADE, FROM THE PERIOD OF 26/JUNE/2019 TO 30/JULY/2019, BEING 52 EMBOSSING IDS MANUFACTURED (PKG0003-PR). THIS MANUFACTURING OUTPUT REPRESENTS 904,025 ASSEMBLED TUBES. THE MATERIAL 91-0786 BATCH 19171, WAS FURTHER USED IN 9 LOTS OF 3 DIFFERENT TRUCOUNT RELATED KITS. THESE KITS WERE 340334 (TRUCOUNT ABSOLUTE COUNTING TUBES, IVD), 342447 (CD3 FITC/CD8 PE/CD45 PERCP/CD4 APC WITH BD TRUCOUNT¿ TUBES) AND 333185 (CD8 FITC/CD38 PE/CD3 PERCP/ANTI-HLA-DR APC WITH BD TRUCOUNT¿ TUBES). THE SUBASSEMBLY PROCESS HAS AUTOMATIC MACHINE ASSEMBLY, WHICH INCLUDES AUTOMATIC VISION SYSTEM FOR DETECTION AND SORTING OF CRITICAL DEFECTS. ASSEMBLED TUBES THAT PASS THE AUTOMATIC INSPECTION, GOES THROUGH 100% VISUAL INSPECTION AND SORTING FOR CRITICAL DEFECTS, WHICH ARE EVALUATED UNDER ALERT AND ACTION LIMITS SYSTEM ESTABLISHED. CRITICAL DEFECTS ARE RELATED TO PHYSICAL CHARACTERISTICS OF RETAINERS, PELLETS, TUBES, LABELS, CAPS, AND SEALED POUCHES. FROM THE 52 EMBOSSING IDS MANUFACTURED OF BATCH 19171, DID NOT REACHED ACTION NOT EVEN ALERT LIMITS ESTABLISHED, BEING UNDER PROCESS CONTROL. IN ADDITION, FOR EACH ASSEMBLY DAYS (52), ALL AQLS PASSED ACCEPTANCE CRITERIA (C=0) FOR TUBE ASSEMBLY INSPECTION AS WELL AS POUCHED TUBE INSPECTION. THERE WERE ZERO (0) OUT OF SPECIFICATION (OOS) OR QUALITY NOTIFICATIONS (QNS) REPORTS RELATED TO THIS ASSEMBLY PROCESS. ROOM CONDITIONS WERE MONITORED AS PART OF THE PROCESS AND MET REQUIREMENTS THROUGHOUT THE MANUFACTURING PERIOD. CRITICAL DEFECTS ARE KNOWN AND RECOGNIZED IN THE ASSEMBLY PROCESS DOCUMENTATION (PKG0003-PR), FOR WHICH THERE ARE CONTROLS IN PLACE. ASSEMBLY PROCESS OCCURRED UNDER ESTABLISHED CONTROLS AND INSTRUCTIONS, WITHOUT DISCREPANCIES OR DEVIATIONS. RAW MATERIAL COMPONENT BEAD PELLET 91-0195 BATCH 8109647 (MANUFACTURED IN PLANT 1149) AND USED IN SUBASSEMBLY 91-0786 BATCH 19171 (MANUFACTURED IN PLANT 1157), WENT THRU INCOMING QA INSPECTION AND MET BD SPECIFICATIONS WITHOUT DISCREPANCIES OR QUALITY NOTIFICATIONS (QNS). THE INFORMATION PROVIDED BY THE CUSTOMER IS THAT NINE (9) OUT OF FORTY (40) SAMPLES TESTED WERE REPEATED WHILE PERFORMING A CD4/CD8 MULTITEST ASSAY. HUMIDITY EXPOSURE OF THE TUBE DOES IMPACT THE BEADS COUNTS OBTAINING ERRONEOUS/INACCURATE RESULTS. FOR THIS REASON, THE TRUCOUNT POUCH LABEL 23-3823-08 ATTACHED TO THE FOIL POUCH ESTABLISHES CLEARLY THE STATEMENT RELATED TO STORAGE AS FOLLOWS: ¿USE TUBES WITHIN 1 MONTH AFTER OPENING THIS POUCH. CAREFULLY, RESEAL POUCH IMMEDIATELY AFTER EACH USE.¿ IN ADDITION, TECHNICAL DATA SHEET (TDS) OR INSTRUCTIONS FOR USE (IFU) FOR 340334 (DOCUMENT NUMBER 23-22402-01) SECTION 3 REAGENT-PRECAUTIONS SECTION INSTRUCTS THE CUSTOMER TO AVOID HUMIDITY EXPOSURE REFERRING TO USING THE TUBE WITHIN ONE (1) HOUR AFTER REMOVAL FROM THE FOIL POUCH. TDS PROVIDES AWARENESS FOR THE POSSIBILITY OF EXPOSURE OF THE TUBES TO AMBIENT MOISTURE BY NOT BEING USE WITHIN ONE HOUR, WHICH COULD RESULT IN INACCURATE RESULTS. THEREFORE, IT IS RECOGNIZED THAT HANDLING FORTY (40) SAMPLES DURING A TEST COULD BE A CHALLENGING EXECUTION, CONSIDERING THAT THE TUBES CANNOT BE EXPOSED FOR MORE THAN ONE (1) HOUR TO AVOID HUMIDITY EXPOSURE. IN ADDITION, BD APPLICATION SPECIALIST STATED ON 06/18/2021 THEY BELIEVE PROBLEM OBSERVED BY THE CUSTOMER IS ORIENTED TOWARDS THE TECHNIQUE AND PREPARATION OF THE SAMPLES BY THE CUSTOMER. INVESTIGATION REVEALS THAT THE CONTROLS IN PLACE FOR THE MANUFACTURING PROCESS WERE FOLLOWED AND IMPLEMENTED, INSPECTION POINTS WERE SUCCESSFUL, NO DEVIATIONS WERE FOUND RELATED TO THE ASSEMBLY PROCESS OF THE MATERIAL SUBASSEMBLY 91-0786 BATCH 19171 OR THE INCOMING QA INSPECTION OF THE PELLET RAW MATERIAL 91-0195 BATCH 8109647. IN ADDITION, MATERIAL 91-0786 BATCH 19171 WAS SHIPPED FROM CAYEY TO SAN JOSE PLANT BEING USED IN FURTHER KITS PRODUCTION, WHERE NO ISSUES RELATED TO POUCH DISRUPTION OR BAD SEALS WHERE REPORTED. THE MATERIALS COMPLIED WITH ALL BDB REQUIREMENTS. IN ADDITION, THERE ARE IN PLACE NUMEROUS IFU ON HOW THE POUCHES AND TUBES SHOULD BE HANDLED AND THERE IS ADVICE FOR THE CUSTOMER RELATED TO USAGE AND STORAGE TO AVOID AND REDUCE HUMIDITY EXPOSURE. INVESTIGATION SHOWS THAT THERE IS NO EVIDENCE OF PHYSICAL DEFECTS RELATED TO THE SUBASSEMBLY PROCESS OF 91-0786 (POUCHED ABSOLUTE COUNT TUBES) BATCH 19171 MANUFACTURED IN BDB CAYEY (PLANT 1157). BDB CAYEY CONTINUES TO MONITOR RELATED CLAIMS ASSOCIATED TO 91-0786 BATCH 19171 TO IDENTIFY EMERGING TRENDS. ¿ RETURNED SAMPLE ANALYSIS: NO RETURNED SAMPLE ANALYSIS WAS COMPLETED SINCE THERE IS NOT DATA TO EVALUATE CUSTOMER RESULTS, NEITHER PICTURE NOR ANY OTHER INFORMATION. INVESTIGATION WAS COMPLETED BASED ON THE INFORMATION PROVIDED IN THE MESSAGES ATTACHED TO THE COMPLAINT. ALSO, BD INTERNAL APPLICATION SPECIALIST COMMUNICATION (DATED 06/18/2021) WAS EVALUATED AS PART OF INVESTIGATION. ¿ RETAIN SAMPLE ANALYSIS: NO RETAIN SAMPLE WAS EVALUATED AS THE INVESTIGATION PERFORMED WAS BASED ON THE INFORMATION PROVIDED IN THE MESSAGES ATTACHED TO THE COMPLAINT. ALSO, BD INTERNAL APPLICATION SPECIALIST COMMUNICATION (DATED 06/18/2021) WAS EVALUATED AS PART OF INVESTIGATION. INVESTIGATION REVEALS THAT THE SUBASSEMBLY PROCESS OF 91-0786 BATCH 19171 OCCURRED UNDER ESTABLISHED CONTROLS, WITHOUT DISCREPANCIES OR DEVIATIONS. IN ADDITION, PELLET RAW MATERIAL 91-0195 LOT 8109647 USED IN SUBASSEMBLY 91-0786 BATCH 19171 MANUFACTURING PROCESS WENT THRU INCOMING QA INSPECTION IN BDB CAYEY (PLANT 1157) AND MATERIAL MET BD SPECIFICATIONS WITHOUT DISCREPANCIES, DEVIATIONS, OR QUALITY NOTIFICATIONS (QNS). INVESTIGATION SHOWS THAT THERE IS NO EVIDENCE OF PHYSICAL DEFECTS RELATED TO THE ASSEMBLY PROCESS. ¿ INVESTIGATION SUMMARY: CUSTOMER (CLINICA DE LA SALUD INTEGRAL, GUATEMALA) REPORTED COMPLAINT ON PRODUCT 340334 (TRUCOUNT ABSOLUTE COUNTING TUBES, IVD) LOT 9224566 ON 25/MAY/2021. THE CLAIM ESTABLISHED ¿PEARL MEASUREMENT PROBLEMS¿ REPORTING AN ERRONEOUS RESULT NEEDING TO REPEAT 9 SAMPLES FROM A TOTAL OF 40 SAMPLES RUN. PRODUCT 340334 LOT 9224566 WAS ASSEMBLED IN BDB SAN JOSE CA (PLANT 1149), USING POUCHED SUBASSEMBLY 91-0786 (POUCHED ABSOLUTE COUNT TUBES PR) BATCH 19171 MANUFACTURED IN BDB CAYEY (PLANT 1157) AND USING TRUCOUNT ABSOLUTE COUNT PELLET SUBASSEMBLY 91-0195 BATCH 8109647 MANUFACTURED IN BDB SAN JOSE CA (PLANT 1149). A REVIEW OF THE MANUFACTURING BATCH RECORD (PKG003-PR) OF MATERIAL SUBASSEMBLY 91-0786 BATCH 19171 WAS COMPLETED. THE SUBASSEMBLY PROCESS IS INSPECTED BY AUTOMATIC ASSEMBLY MACHINE VISION SYSTEM FOR DETECTION AND SORTING OF CRITICAL DEFECTS, THEN ASSEMBLED TUBES THAT PASS AUTOMATED INSPECTION GOES THROUGH A VISUAL 100% INSPECTION AND SORTING OF CRITICAL DEFECTS, WHICH RESULTS ARE EVALUATED AGAINST AN ESTABLISHED ALERT AND ACTION LIMITS SYSTEM. THE CRITICAL DEFECTS ARE RELATED TO PHYSICAL CHARACTERISTICS OF RETAINERS, PELLETS, TUBES, LABELS, CAPS, AND SEALED POUCHES. NONE OF THE ASSEMBLY MANUFACTURING DATES OF BATCH 19171 SHOWED ALERT OR ACTION LIMITS REACHED FOR CRITICAL DEFECTS AFTER THE 100% INSPECTION PROCESS (AS REPORTED ON MF0183-PR-04 DOCUMENT). IN ADDITION, FOR EACH ASSEMBLY DAY (52 IN TOTAL), ALL AQLS PASSED ACCEPTANCE CRITERIA (C=0). THUS, THE ASSEMBLY PROCESS OF MATERIAL 91-0786 BATCH 19171OCCURRED UNDER ESTABLISHED CONTROLS, WITHOUT DISCREPANCIES OR DEVIATIONS. SINCE THE CUSTOMER CLAIM IS RELATED TO ERRONEOUS RESULTS, ALSO THE PELLET RAW MATERIAL WAS EVALUATED. PELLET RAW MATERIAL 91-0195 BATCH 8109647 USED IN SUBASSEMBLY 91-0786 BATCH 19171 MANUFACTURING PROCESS WENT THROUGH INCOMING QA INSPECTION IN BDB CAYEY (PLANT 1157) AND MATERIAL MET BD SPECIFICATIONS WITHOUT DISCREPANCIES, DEVIATIONS, OR QUALITY NOTIFICATIONS (QNS). EVALUATION OF PROVIDED CUSTOMER INFORMATION: NINE (9) OUT OF FORTY (40) SAMPLES TESTED WERE REPEATED WHILE PERFORMING A CD4/CD8 MULTITEST ASSAY. HUMIDITY EXPOSURE OF THE TUBE DOES IMPACT THE BEADS COUNTS OBTAINING ERRONEOUS/INACCURATE RESULTS. FOR THIS REASON, TDS 340334 (DOCUMENT NUMBER 23-22402-01) SECTION 3 REAGENT-PRECAUTIONS SECTION INSTRUCTS THE CUSTOMER TO AVOID HUMIDITY EXPOSURE REFERRING TO USING THE TUBE WITHIN ONE (1) HOUR AFTER REMOVAL FROM THE FOIL POUCH. THEREFORE, IT IS RECOGNIZED THAT HANDLING FORTY (40) SAMPLES DURING A TEST COULD BE A CHALLENGING EXECUTION, CONSIDERING THAT THE TUBES CANNOT BE EXPOSED FOR MORE THAN ONE (1) HOUR TO AVOID HUMIDITY EXPOSURE. BD APPLICATION SPECIALIST STATED ON 06/18/2021 THEY BELIEVE PROBLEM OBSERVED BY THE CUSTOMER IS ORIENTED TOWARDS THE TECHNIQUE AND PREPARATION OF THE SAMPLES BY THE CUSTOMER. BASED ON THE INVESTIGATION RESULT, ROOT CAUSE CANNOT BE DETERMINED. BUT INVESTIGATION SHOWS THAT THERE IS NO EVIDENCE OF PHYSICAL DEFECTS RELATED TO THE SUBASSEMBLY PROCESS OF 91-0786 (POUCHED ABSOLUTE COUNT TUBES) BATCH 19171 MANUFACTURED IN BDB CAYEY (PLANT 1157). BASED ON THE INVESTIGATION RESULT, THE COMPLAINT IS CONSIDERED UNCONFIRMED. THERE IS NO FURTHER INVESTIGATION OR ACTIONS REQUIRED. BDB CAYEY CONTINUES TO MONITOR RELATED CLAIMS ASSOCIATED TO 91-0786 BATCH 19171 TO IDENTIFY EMERGING TRENDS. REFER TO PARENT PR2970899 FOR INVESTIGATION DETAILS. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULT, COMPLAINT WAS UNCONFIRMED. H3 OTHER TEXT : SEE H10
IT WAS REPORTED WHILE TESTING WITH BD TRUCOUNT¿ TUBES ERRONEOUS RESULTS WERE OBTAINED WITH 9 PATIENT SAMPLES. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: PEARL MEASUREMENT PROBLEMS. YESTERDAY THE CLIENT TELLS US THAT HE CONTINUES WITH THE SAME PROBLEM OF 40 SAMPLES, 9 HAD TO BE REPEATED SINCE THE RESULTS DID NOT CORRESPOND WITH THE PATIENT'S HISTORY.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHILE TESTING WITH BD TRUCOUNT¿ TUBES ERRONEOUS RESULTS WERE OBTAINED WITH 9 PATIENT SAMPLES. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: PEARL MEASUREMENT PROBLEMS. YESTERDAY THE CLIENT TELLS US THAT HE CONTINUES WITH THE SAME PROBLEM OF 40 SAMPLES, 9 HAD TO BE REPEATED SINCE THE RESULTS DID NOT CORRESPOND WITH THE PATIENT'S HISTORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 934000 | BD TRUCOUNT TUBES | COUNTER, DIFFERENTIAL CELL | GKZ | BECTON DICKINSON CARIBE LTD. | 340334 | 9224566 | 00382903403349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |