TUBE PMS PLH 13X100 3.5 PLBL LIM CE
Report
- Report Number
- 9617032-2021-00426
- Event Type
- Malfunction
- Date Received
- May 11, 2021
- Date of Event
- February 16, 2021
- Report Date
- June 4, 2021
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION: BD DID NOT RECEIVE SAMPLES OR PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. 20 RETAINED SAMPLES FROM EACH LOT NUMBER PROVIDED WERE DRAW-TESTED WITH DEIONIZED WATER. FROM THIS TESTING IT WAS DETERMINED THAT ALL 60 TUBES DREW WITHIN SPECIFICATION. 20 RETAINED TUBES FROM EACH LOT NUMBER PROVIDED WERE ANALYZED FOR THE HEPARIN CONTENT FROM AND WERE ALL WITHIN SPEC LIMITS. BD WAS UNABLE TO CONFIRM CUSTOMERS INDICATED FAILURE MODE BASED ON THE RETAINED SAMPLES TEST RESULTS. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS.
MEDICAL DEVICE LOT #: IT CANNOT BE CONFIRMED WHICH LOT WAS USED IN THOSE INCIDENTS, BUT THE CLIENT INFORMED US THAT LOTS USED AT THAT TIMEFRAME ARE: MEDICAL DEVICE LOT #: 0245303 MEDICAL DEVICE EXPIRATION DATE: 2022-01-31 DEVICE MANUFACTURE DATE: 2020-09-01. MEDICAL DEVICE LOT #: 1004592 MEDICAL DEVICE EXPIRATION DATE: 2022-04-22 DEVICE MANUFACTURE DATE: 2021-01-04. MEDICAL DEVICE LOT #: 1039510 MEDICAL DEVICE EXPIRATION DATE: 2021-03-06 DEVICE MANUFACTURE DATE: 2021-02-08. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHEN USING THE TUBE PMS PLH 13X100 3.5 PLBL LIM CE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD AND ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATE: THERE IS AN ISSUE WITH FALSE POSITIVES AND NORMAL VALUES AFTER RETESTING. THE TUBES ARE USED ONLY BY THE EMERGENCY DEPARTMENT. INITIAL REPORTER: BARRICOR : REF 365053. LOTS: NOT KNOWN BY THE CUSTOMER, SEVERAL LOTS USED ACCORDING TO HIM ABBOTT TROPONIN I HS ON ARCHITECT (2 INSTRUMENTS). CENTRIFUGATION 11 MIN, 2250G ON THE INPECO CHAIN. PROBLEM OF FALSE POSITIVES, AND NORMAL VALUES AFTER RETESTING. TUBES USED ONLY BY THE EMERGENCY DEPARTMENT. DATE OF INFORMATION REPORTED BY THE CUSTOMER: ON (B)(6) 2021. CUSTOMER DID NOT NOTIFY BD. MANAGED THE PROBLEM WITH ABBOTT THINKING IT WAS A MACHINE AND REAGENT PROBLEM. NON-CONFORMITY WRITTEN BY THE CH TO THIS EMAIL. SMALL SIZE TUBES 13*75 ARE SENT FOR TESTING. TO BE CHECKED : THE HOMOGENIZATION OF THE TUBES. CLIENT'S EMAIL: TO ADD AN ADDITIONAL AND VERY RECENT ELEMENT TO THE NON-COMPLIANCE OF WHICH WE HAVE SENT YOU A COPY, I INFORM YOU THAT WE HAD AGAIN A CONCERN OF ERRONEOUS TROPONIN RESULT YESTERDAY AT 5:30 PM. THE SAMPLE WAS TAKEN ON A BARICOR TUBE, CORRECTLY FILLED. THE FIRST RESULT WAS 148.3 NG/L, CHECKED AT 23 NG/L. WE HAD NO MORE PROBLEMS SINCE ON (B)(6) THE DAY WE REMOVED THE BARICOR TUBES FROM THE EMERGENCY ROOM. OUR MACHINES ARE FUNCTIONAL, SO AFTER HAVING ATTRIBUTED THE IDENTIFIED PROBLEMS TO TECHNICAL ISSUES, WE ARE NOW MORE INCLINED TOWARDS A PRE-ANALYTICAL ORIGIN OF THE PROBLEM. NO OTHER BARICOR + ABBOTT USER HAS A PROBLEM? CLIENT'S DOCUMENTATION: DESCRIPTION: ON (B)(6) 2021 AT 10:04 P.M.: WE RETURNED A TROPONIN RESULT FROM MRS. X AT 111.4 NG/L (SAMPLE #: (B)(4), THE PHYSICIAN SURPRISED BY THIS RESULT NOT CONCORDANT WITH THE CLINICAL PICTURE REQUESTED A CONTROL SAMPLE WHICH WAS ASSAYED AT 11:38 P.M. AT 1.5 NG/L (SAMPLE #: (B)(4) (THESE TWO ASSAYS WERE PERFORMED ON THE SATURNE ISR54471 (115575) MACHINE. IMMEDIATE ACTION TAKEN: IN VIEW OF THIS SIGNIFICANT DECREASE IN TROPONIN, THE TECHNICIAN DECIDED TO REPEAT THE 2 SAMPLES ON THE SECOND INSTRUMENT AT 00:04 ON (B)(6) 2021 (VENUS ISR54469 (115577)) WITH RESULTS AT 0.7 NG/L (SAMPLE NO: (B)(4) AND 0.6 NG/L (SAMPLE NO: (B)(4). IN VIEW OF THE PATIENT'S CLINICAL PICTURE AND IN AGREEMENT WITH THE PHYSICIAN WE RETURNED THE VENUS RESULT FOR SAMPLE: (B)(4) AS 0.7 NG/L. CAUSE ANALYSIS: ON (B)(6) 2021, FOLLOWING THIS ANOMALY WE PERFORMED A REPEATABILITY THE NEXT DAY ON THE 2 INSTRUMENTS ON THE PROBLEMATIC SAMPLE: (B)(4). THE RESULTS ARE ABERRANT ON SATURNE ISR54471 WITH A RESULT AT 146,7 NG/L AND THE 2 OTHER REPLICAS AT 2,9 AND 1,6 NG/L. ON VENUS THE 2 REPLICATES ARE CORRECT. WE TESTED OTHER PATIENTS OF THE DAY AND THE REPRODUCIBILITY WAS GOOD ON SATURNE. WE MADE A RETROSPECTIVE STUDY ON (B)(6) 2021 TO LOOK FOR POSSIBLE OTHER ERRORS: NO ANOMALY FOUND. ON (B)(6) 2021: RESPONSE FROM ABBOTT BY TELEPHONE, WHICH SUSPECTED EITHER A CENTRIFUGATION PROBLEM OR A PROBLEM WITH THE STAT NEEDLES: CHECKED CENTRI PROGRAMS OK. STUDY OF PIPETTING ERRORS FOR SEVERAL DAYS: MOST SAMPLING ERRORS ARE MADE ON BARRICOR TUBES COMING FROM EMERGENCIES WHICH MUST BE BADLY FILLED AND THEREFORE THE STAT NEEDLE HITS THE RING OF THE TUBE WHICH IS USED TO MAKE THE SEAL. ON (B)(6) 2021: NEW MALFUNCTION: ON THE NIGHT ON (B)(6) 2021 AT 22:54: WE RETURNED A TROPONIN RESULT FROM MR F AT 246.9 NG/L (SAMPLE NO: (B)(4), WITH A CONTROL SAMPLE THAT WAS ASSAYED ON (B)(6) 2021 AT 02:17 AT 2.8 NG/L (SAMPLE NO: (B)(4) (THESE TWO ASSAYS WERE THIS TIME PERFORMED ON THE VENUS ISR54469 (115577) MACHINE). IN VIEW OF THIS SIGNIFICANT DECREASE IN TROPONIN, THE TECHNICIAN DECIDED TO REPEAT THE 2 SAMPLES ON THE SECOND AUTOMATON AT 02:46 AND 03:02 (SATURNE ISR54471 (115577) WITH RESULTS OF 44.8 NG/L (SAMPLE NUMBER: (B)(4) AND 3.4 NG/L (SAMPLE NUMBER: (B)(4). SENT AN EMAIL TO THE EMERGENCY ROOM MANAGERS TO ALERT THEM TO THE FILLING OF THE BARRICORS TUBES. (B)(6) CALLED FROM DR. (B)(6) TO WARN ABOUT THE MALFUNCTION AND NOT TO HESITATE TO CHECK DISCORDANT TROPONINS WITH THE CLINIC. CHANGED SATURNE AND VENUS STAT NEEDLES TODAY. RESPONSE FROM ABBOTT TO CHANGE SENSORS ON STAT NEEDLES. ON (B)(6) 2021: CHANGED STAT NEEDLE SENSORS PERFORMED THIS DAY, NO NEW TROPONIN ERRORS. INFO MADE IN SERVICE MEETING AND BIOCHEMISTRY BIOLOGIST TO BE VIGILANT ON TROPO ERRORS AND BARRICOR TUBE FILLING. TO BE CONTINUED. ON (B)(6) 2021 AT 05:36: NEW MALFUNCTION: WE RETURNED A TROPONIN RESULT FROM MRS. (B)(6) AT 100.1 NG/L (SAMPLE#: (B)(4), WITH A CONTROL SAMPLE THAT WAS ASSAYED ON (B)(6) 2021 AT 11:49 AM AT 1.2 NG/L (SAMPLE#: (B)(4) (BOTH ASSAYS WERE PERFORMED ON THE SATURNE ISR54471 (115575). IN VIEW OF THIS SIGNIFICANT DECREASE IN TROPONIN, WE DECIDED TO REPEAT SAMPLE: (B)(4) ON (B)(6) 2021 AT 14:46 (ON SATURNE ISR54471 (115575) WITH A RESULT OF 1.4 NG/L. INFORMATION GIVEN TO ABBOTT. ON (B)(6), TWO NEW MALFUNCTIONS OCCURRED. BOTH WERE TRANSMITTED TO ABBOTT AGAIN BY E-MAIL BY (B)(6). ON (B)(6): NEW INSTRUCTION GIVEN TO THE TECHNICIANS TO RUN AGAIN ALL THE SAMPLES BETWEEN 100 AND 300 NG/ML, WHICH MADE IT POSSIBLE TO IDENTIFY A NEW DYSFUNCTION BEFORE THE RELEASE OF THE RESULT. TRANSMISSION MADE AGAIN BY E-MAIL TO ABBOTT. ON (B)(6): CREATED AN ASSESSMENT RULE ON BY (B)(6) TO AUTOMATE THE RETESTING OF SAMPLES BETWEEN 100 AND 300 NG/ML . THE INFORMATION WAS MADE TO THE SERVICE VIA AN INFORMATION NOTE . REPEATABILITY PERFORMED ON SATURNE WITH A SAMPLE RETURNED AT 21 NG/ML. REPEATABILITY OK WITH CV AT 4.3%. (B)(6) CAME TODAY ON SITE TO EVALUATE THE SATURNE AND VENUS AUTOMATONS. SHE PERFORMED EXTENSIVE MAINTENANCE MAINLY ON VENUS, INCLUDING PARTS CHANGES ON THE WASH STATIONS AND VACUUM PUMP. ON (B)(6): NEW MALFUNCTION ON VENUS INFORMATION OF THIS NEW EVENT BY EMAIL TO ABBOTT AND (B)(6) CALL THIS AFTERNOON FROM (B)(6), SHE ADVISES US TO CHANGE THE R2 REAGENT NEEDLE AND A NEW CALIBRATION PLANNED FOR TOMORROW ON (B)(6) 2021 DURING THE DAILY MAINTENANCE OF VENUS. ALSO PLANNED: A CONTAMINATION STUDY WITH A STRONG SAMPLE (TROPONIN > 2000 NG/L) AFTER THE NEEDLE CHANGE AND THE NEW CALIBRATION. ON (B)(6): VENUS R2 NEEDLE CHANGE AND CALIBRATION. ON (B)(6): VENUS CONTAMINATION STUDIES: NO 1: WITH A POOL OF PATIENTS WITH TROPONIN > 50000NG/L AND A POOL OF PATIENTS AT 50 NG/L NO CONTAMINATION. NO 2: WITH A POOL OF PATIENTS AT 20000 NG/L AND A PATIENT < 3 NG/L NO CONTAMINATION. ON (B)(6): CONTAMINATION STUDY ON SATURNE: WITH A POOL OF PATIENTS AT 20000 NG/L AND ONE PATIENT < 3 NG/L CONTAMINATION ON SEQUENCE 2 NOT CALCULABLE BECAUSE GAP BETWEEN HIGH AND LOW VALUES TOO LARGE TO RENDER A MEANINGFUL RESULT WITH THE CONTAMINATION FORMULA. REFER TO THE OBSERVED BIAS. THEN CHANGE THE VACUUM PUMP OF SATURNE AND THE R2 NEEDLE BY (B)(6). ON (B)(6): NEW CONTAMINATION STUDY ON SATURNE AFTER CHANGE OF THE VACUUM PUMP AND THE R2 NEEDLE LAST FRIDAY: WITH A STRONG POSITIVE PATIENT AND A NEGATIVE PATIENT CONTAMINATION ON SEQUENCE 3 AND LACK OF REPEATABILITY ON SEQUENCES 1 AND 2. NEW HYPOTHESIS: SUSPICION OF BETAHCG CONTAMINATION (BECAUSE SAME STAT NEEDLE). STUDY OF CONTAMINATION ON SATURN WITH A STRONG POSITIVE PATIENT AND A NEGATIVE PATIENT NO CONTAMINATION. NEW MALFUNCTION: DETERMINATION OF A TROPONIN AT 244 NG/L. TAKING INTO ACCOUNT OUR PREVIOUSLY EXPLAINED EXPERTISE RULES (RE-RUN OF ALL SAMPLES WITH A TROPONIN BETWEEN 100 AND 300 NG/L), WE RE-RUN THIS SAMPLE WHICH CAME BACK AT 152.1 NG/L. IT WAS NEITHER HEMOLYZED, NOR LACTESCENT, NOR IN A BARRICOR TUBE. WE THEREFORE REPEATED THE TEST A THIRD TIME, THIS TIME WITH A RESULT OF 169.5 NG/L. INFORMATION GIVEN TO ABBOTT. ON (B)(6): (B)(6) CAME THIS DAY ON SITE TO CONTINUE THE EXPLORATIONS ON SATURN AND VENUS. SHE CHANGED, AMONG OTHER THINGS, THE 3 NEEDLES OF THE WASHING AREA OF THE TWO INSTRUMENTS. HER INTERVENTION REPORTS ARE AVAILABLE IN THE FILE PROVIDED FOR THIS PURPOSE. NEW STUDY OF CONTAMINATION: NO CONTAMINATION. ON (B)(6): STUDY OF CONTAMINATION ON VENUS AFTER THE INTERVENTIONS ON (B)(6) CARRIED OUT BY (B)(6): NO CONTAMINATION. ON (B)(6): NEW MALFUNCTION: SAMPLE #1 RETURNED AT 453.2 NG/L TROPONIN, TROPONIN CYCLE CONTROL RETURNED AT 3.5 NG/L 2 HOURS LATER. THE REPLAY OF SAMPLE NO. 1 SHOWS A RESULT OF 2.2 NG/L . PASSAGE OF PATIENT SAMPLE ON SATURN. INFORMATION GIVEN TO ABBOTT. ON (B)(6): CHANGE IN VALIDATION RULE FOR TECHNICIANS, TRANSMISSION MADE BY ATTACHED INFORMATION NOTE . ALL SAMPLES RETURNING TROPONIN > 100 NG/L WITHOUT RECENT HISTORY MUST BE RE-RUN FOR VERIFICATION. ON (B)(6): NEW MALFUNCTION: FIRST RUN OF A SAMPLE WITH 199.8 NG/L TROPONIN, CHECKED (ACCORDING TO TECHNICIAN VALIDATION RULES) AT 1.6 NG/L. SECOND RUN AT 2.1 NG/L. ALL THREE RUNS WERE PERFORMED ON VENUS. ON (B)(6): (B)(6) CAME WITH A LEAD SPECIALIST: THEY LOADED THE LOGS FROM THE LAST TWO MONTHS, THEN CHANGED ALL THE SATURN WASH STATIONS, EMPTIED AND BLEACHED THE NEEDLE CLEANING BUFFER TANK, AND RECHANGED THE VACUUM PUMP. (B)(6) (ABBOTT SALES REPRESENTATIVE) AND MR. (B)(6) (CUSTOMER EXPERIENCE DIRECTOR) CAME TO SEE US: A PRIORI, THERE WAS NO APPARENT PROBLEM WITH TROPONIN IN THE OTHER FRENCH LABORATORIES EQUIPPED BY ABBOTT. INVESTIGATIONS PLANNED WITH (B)(6) FOR THE EUROPEAN LABORATORIES. AS A REMINDER, THE VALIDATION RULE IS MAINTAINED (REPEAT OF ALL TROPONINS > 100 NG/L WITHOUT RECENT HISTORY). THE RE-RECALL RATE HAS INCREASED FROM 0.1% IN 2020 TO 13.75% SINCE THIS VALIDATION RULE. C.L AND MR. (B)(6) WILL MAKE ARRANGEMENTS TO COMPENSATE FOR THE EXTRA REAGENT COST AT THE END OF THE MALFUNCTION. ON (B)(6): MAIL FROM ABBOTT'S CUSTOMER SERVICE: OUR FILE HAS BEEN FORWARDED TO THE PRODUCT QUALITY TEAMS RESPONSIBLE FOR FURTHER INVESTIGATIONS. ON (B)(6): TEMPORARY WITHDRAWAL OF BARRICOR TUBES IN THE EMERGENCY ROOM. POSSIBLE MALFUNCTION DUE TO THE BARRICOR TUBES THEMSELVES OR TO THE PRE-ANALYSIS (CENTRIFUGATION PROGRAM NOT ADAPTED TO THESE TUBES). 21/APR/2021: UPDATE: REGARDING THE BARRICOR TUBE FILLING PROBLEM, WE USE THESE TUBES IN THE EMERGENCY DEPARTMENT THAT COLLECTS ON KT. AND IT IS LIKELY THAT, ON A SIGNIFICANT NUMBER OF SAMPLES, THE PURGE TUBE IS NOT USED. THE USE OF BARRICOR LOW-VACUUM TUBES THEREFORE DOES NOT ALLOW FOR OPTIMAL FILLING. TROPONIN MALFUNCTIONS ON "BARRICOR TUBE" HAVE BEEN FOUND ON WELL-FILLED TUBES. WE HAVE REDUCED THE RISK FOR THE PATIENT BY CONTROLLING SINCE ON (B)(6) ALL TROPONINS > 100 NG/L. ONLY 2 SAMPLES WERE RETURNED WITH AN ERRONEOUS RESULT. FOR THE OTHERS, WE HAVE MADE UP FOR THE ERROR BY SYSTEMATICALLY CHECKING THE ASSAYS BEFORE VALIDATION. THIS RESULTED IN AN INCREASE IN THE TIME REQUIRED TO RETURN THE RESULT. THE PATIENTS FOR WHOM A HIGH VALUE IS RETURNED IN THE FIRST INSTANCE ARE SUBJECT TO INCREASED SURVEILLANCE IN THE EMERGENCY ROOM, LEADING TO AN INCREASE IN THE LENGTH OF HOSPITALIZATION. WE HAVE BEEN OBLIGED TO INFORM THE CLINICIANS OF THIS FACT, ALSO CALLING ON THEM TO BE MORE VIGILANT. REGARDING YOUR PROPOSAL TO SEND TUBES, WE THINK THAT IT IS NOT NECESSARY.
IT WAS REPORTED WHEN USING THE TUBE PMS PLH 13X100 3.5 PLBL LIM CE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD AND ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATE: THERE IS AN ISSUE WITH FALSE POSITIVES AND NORMAL VALUES AFTER RETESTING. THE TUBES ARE USED ONLY BY THE EMERGENCY DEPARTMENT. INITIAL REPORTER: BARRICOR : REF 365053 LOTS: NOT KNOWN BY THE CUSTOMER, SEVERAL LOTS USED ACCORDING TO HIM ABBOTT TROPONIN I HS ON ARCHITECT (2 INSTRUMENTS). CENTRIFUGATION 11 MIN, 2250G ON THE INPECO CHAIN. PROBLEM OF FALSE POSITIVES, AND NORMAL VALUES AFTER RETESTING. TUBES USED ONLY BY THE EMERGENCY DEPARTMENT. DATE OF INFORMATION REPORTED BY THE CUSTOMER: (B)(6) 2021 CUSTOMER DID NOT NOTIFY BD. MANAGED THE PROBLEM WITH ABBOTT THINKING IT WAS A MACHINE AND REAGENT PROBLEM. NON-CONFORMITY WRITTEN BY THE CH ATTACHED TO THIS EMAIL. SMALL SIZE TUBES 13*75 ARE SENT FOR TESTING. TO BE CHECKED : THE HOMOGENIZATION OF THE TUBES CLIENT'S EMAIL: TO ADD AN ADDITIONAL AND VERY RECENT ELEMENT TO THE NON-COMPLIANCE OF WHICH WE HAVE SENT YOU A COPY, I INFORM YOU THAT WE HAD AGAIN A CONCERN OF ERRONEOUS TROPONIN RESULT YESTERDAY AT 5:30 PM. THE SAMPLE WAS TAKEN ON A BARICOR TUBE, CORRECTLY FILLED. THE FIRST RESULT WAS 148.3 NG/L, CHECKED AT 23 NG/L. WE HAD NO MORE PROBLEMS SINCE MARCH 25, THE DAY WE REMOVED THE BARICOR TUBES FROM THE EMERGENCY ROOM. OUR MACHINES ARE FUNCTIONAL, SO AFTER HAVING ATTRIBUTED THE IDENTIFIED PROBLEMS TO TECHNICAL ISSUES, WE ARE NOW MORE INCLINED TOWARDS A PRE-ANALYTICAL ORIGIN OF THE PROBLEM.... NO OTHER BARICOR + ABBOTT USER HAS A PROBLEM? CLIENT'S DOCUMENTATION: DESCRIPTION: ON (B)(6) 2021 AT 10:04 P.M.: WE RETURNED A TROPONIN RESULT FROM MRS. X AT 111.4 NG/L (SAMPLE #(B)(6)), THE PHYSICIAN SURPRISED BY THIS RESULT NOT CONCORDANT WITH THE CLINICAL PICTURE REQUESTED A CONTROL SAMPLE WHICH WAS ASSAYED AT 11:38 P.M. AT 1.5 NG/L (SAMPLE #(B)(6)) (THESE TWO ASSAYS WERE PERFORMED ON THE SATURNE (B)(4) MACHINE IMMEDIATE ACTION TAKEN: IN VIEW OF THIS SIGNIFICANT DECREASE IN TROPONIN, THE TECHNICIAN DECIDED TO REPEAT THE 2 SAMPLES ON THE SECOND INSTRUMENT AT 00:04 ON (B)(6) 2021 (VENUS (B)(4)) WITH RESULTS AT 0.7 NG/L (SAMPLE NO. (B)(6)) AND 0.6 NG/L (SAMPLE NO. (B)(6)). IN VIEW OF THE PATIENT'S CLINICAL PICTURE AND IN AGREEMENT WITH THE PHYSICIAN WE RETURNED THE VENUS RESULT FOR SAMPLE (B)(6) AS 0.7 NG/L. CAUSE ANALYSIS: (B)(6) 2021 FOLLOWING THIS ANOMALY WE PERFORMED A REPEATABILITY THE NEXT DAY ON THE 2 INSTRUMENTS ON THE PROBLEMATIC SAMPLE (B)(6). THE RESULTS ARE ABERRANT ON SATURNE (B)(4) WITH A RESULT AT 146,7 NG/L AND THE 2 OTHER REPLICAS AT 2,9 AND 1,6 NG/L. ON VENUS THE 2 REPLICATES ARE CORRECT. WE TESTED OTHER PATIENTS OF THE DAY AND THE REPRODUCIBILITY WAS GOOD ON SATURNE. WE MADE A RETROSPECTIVE STUDY ON (B)(6) 2021 TO LOOK FOR POSSIBLE OTHER ERRORS: NO ANOMALY FOUND. ON (B)(6) 2021: RESPONSE FROM ABBOTT BY TELEPHONE, WHICH SUSPECTED EITHER A CENTRIFUGATION PROBLEM OR A PROBLEM WITH THE STAT NEEDLES: - CHECKED CENTRI PROGRAMS OK. - STUDY OF PIPETTING ERRORS FOR SEVERAL DAYS: MOST SAMPLING ERRORS ARE MADE ON BARRICOR TUBES COMING FROM EMERGENCIES WHICH MUST BE BADLY FILLED AND THEREFORE THE STAT NEEDLE HITS THE RING OF THE TUBE WHICH IS USED TO MAKE THE SEAL. THE (B)(6) 2021: NEW MALFUNCTION: - ON THE NIGHT OF (B)(6) 2021 AT 22:54: WE RETURNED A TROPONIN RESULT FROM MR F AT 246.9 NG/L (SAMPLE NO. (B)(6)), WITH A CONTROL SAMPLE THAT WAS ASSAYED ON (B)(6) 2021 AT 02:17 AT 2.8 NG/L (SAMPLE NO. (B)(6)) (THESE TWO ASSAYS WERE THIS TIME PERFORMED ON THE VENUS (B)(4) MACHINE). IN VIEW OF THIS SIGNIFICANT DECREASE IN TROPONIN, THE TECHNICIAN DECIDED TO REPEAT THE 2 SAMPLES ON THE SECOND AUTOMATON AT 02:46 AND 03:02 (SATURNE (B)(4) WITH RESULTS OF 44.8 NG/L (SAMPLE NUMBER (B)(6)) AND 3.4 NG/L (SAMPLE NUMBER (B)(6)). - SENT AN EMAIL TO THE EMERGENCY ROOM MANAGERS TO ALERT THEM TO THE FILLING OF THE BARRICORS TUBES. (B)(6) CALLED FROM DR. (B)(6) TO WARN ABOUT THE MALFUNCTION AND NOT TO HESITATE TO CHECK DISCORDANT TROPONINS WITH THE CLINIC. - CHANGED SATURNE AND VENUS STAT NEEDLES TODAY. - RESPONSE FROM ABBOTT TO CHANGE SENSORS ON STAT NEEDLES. (B)(6) 2021: - CHANGED STAT NEEDLE SENSORS PERFORMED THIS DAY, NO NEW TROPONIN ERRORS. - INFO MADE IN SERVICE MEETING AND BIOCHEMISTRY BIOLOGIST TO BE VIGILANT ON TROPO ERRORS AND BARRICOR TUBE FILLING. TO BE CONTINUED. (B)(6) 2021 AT 05:36: NEW MALFUNCTION: - WE RETURNED A TROPONIN RESULT FROM MRS. (B)(6) AT 100.1 NG/L (SAMPLE #(B)(6)), WITH A CONTROL SAMPLE THAT WAS ASSAYED ON (B)(6) 2021 AT 11:49 AM AT 1.2 NG/L (SAMPLE #(B)(6)) (BOTH ASSAYS WERE PERFORMED ON THE SATURNE (B)(4)). - IN VIEW OF THIS SIGNIFICANT DECREASE IN TROPONIN, WE DECIDED TO REPEAT SAMPLE (B)(6) ON (B)(6) 2021 AT 14:46 (ON SATURNE (B)(4)) WITH A RESULT OF 1.4 NG/L. - INFORMATION GIVEN TO ABBOTT. ON (B)(6), TWO NEW MALFUNCTIONS OCCURRED. BOTH WERE TRANSMITTED TO ABBOTT AGAIN BY E-MAIL BY (B)(6). ON (B)(6): NEW INSTRUCTION GIVEN TO THE TECHNICIANS TO RUN AGAIN ALL THE SAMPLES BETWEEN 100 AND 300 NG/ML, WHICH MADE IT POSSIBLE TO IDENTIFY A NEW DYSFUNCTION BEFORE THE RELEASE OF THE RESULT. TRANSMISSION MADE AGAIN BY E-MAIL TO ABBOTT. 01/03: - CREATED AN ASSESSMENT RULE ON BYG TO AUTOMATE THE RETESTING OF SAMPLES BETWEEN 100 AND 300 NG/ML . THE INFORMATION WAS MADE TO THE SERVICE VIA AN INFORMATION NOTE . - REPEATABILITY PERFORMED ON SATURNE WITH A SAMPLE RETURNED AT 21 NG/ML. REPEATABILITY OK WITH CV AT 4.3%. - (B)(6) CAME TODAY ON SITE TO EVALUATE THE SATURNE AND VENUS AUTOMATONS. SHE PERFORMED EXTENSIVE MAINTENANCE MAINLY ON VENUS, INCLUDING PARTS CHANGES ON THE WASH STATIONS AND VACUUM PUMP. 09/03: - NEW MALFUNCTION ON VENUS - INFORMATION OF THIS NEW EVENT BY EMAIL TO ABBOTT AND (B)(6). - CALL THIS AFTERNOON FROM (B)(6). SHE ADVISES US TO CHANGE THE R2 REAGENT NEEDLE AND A NEW CALIBRATION >> PLANNED FOR TOMORROW 10/03/2021 DURING THE DAILY MAINTENANCE OF VENUS. - ALSO PLANNED: A CONTAMINATION STUDY WITH A STRONG SAMPLE (TROPONIN > 2000 NG/L) AFTER THE NEEDLE CHANGE AND THE NEW CALIBRATION. 10/03: - VENUS R2 NEEDLE CHANGE AND CALIBRATION. (B)(6): - VENUS CONTAMINATION STUDIES: NO 1: WITH A POOL OF PATIENTS WITH TROPONIN > 50000NG/L AND A POOL OF PATIENTS AT 50 NG/L >>> NO CONTAMINATION. NO 2: WITH A POOL OF PATIENTS AT 20000 NG/L AND A PATIENT < 3 NG/L >>> NO CONTAMINATION (B)(6): - CONTAMINATION STUDY ON SATURNE: WITH A POOL OF PATIENTS AT 20000 NG/L AND ONE PATIENT < 3 NG/L >>> CONTAMINATION ON SEQUENCE 2 NOT CALCULABLE BECAUSE GAP BETWEEN HIGH AND LOW VALUES TOO LARGE TO RENDER A MEANINGFUL RESULT WITH THE CONTAMINATION FORMULA. REFER TO THE OBSERVED BIAS. - THEN CHANGE THE VACUUM PUMP OF SATURNE AND THE R2 NEEDLE BY (B)(6). ON (B)(6): - NEW CONTAMINATION STUDY ON SATURNE AFTER CHANGE OF THE VACUUM PUMP AND THE R2 NEEDLE LAST FRIDAY: WITH A STRONG POSITIVE PATIENT AND A NEGATIVE PATIENT >>> CONTAMINATION ON SEQUENCE 3 AND LACK OF REPEATABILITY ON SEQUENCES 1 AND 2. - NEW HYPOTHESIS: SUSPICION OF BETAHCG CONTAMINATION (BECAUSE SAME STAT NEEDLE). STUDY OF CONTAMINATION ON SATURN WITH A STRONG POSITIVE PATIENT AND A NEGATIVE PATIENT >>> NO CONTAMINATION. - NEW MALFUNCTION: DETERMINATION OF A TROPONIN AT 244 NG/L. TAKING INTO ACCOUNT OUR PREVIOUSLY EXPLAINED EXPERTISE RULES (RE-RUN OF ALL SAMPLES WITH A TROPONIN BETWEEN 100 AND 300 NG/L), WE RE-RUN THIS SAMPLE WHICH CAME BACK AT 152.1 NG/L. IT WAS NEITHER HEMOLYZED, NOR LACTESCENT, NOR IN A BARRICOR TUBE. WE THEREFORE REPEATED THE TEST A THIRD TIME, THIS TIME WITH A RESULT OF 169.5 NG/L. INFORMATION GIVEN TO ABBOTT. 16/03: - (B)(6) CAME THIS DAY ON SITE TO CONTINUE THE EXPLORATIONS ON SATURN AND VENUS. - SHE CHANGED, AMONG OTHER THINGS, THE 3 NEEDLES OF THE WASHING AREA OF THE TWO INSTRUMENTS. HER INTERVENTION REPORTS ARE AVAILABLE IN THE FILE PROVIDED FOR THIS PURPOSE. - NEW STUDY OF CONTAMINATION: NO CONTAMINATION. (B)(6) : - STUDY OF CONTAMINATION ON VENUS AFTER THE INTERVENTIONS OF (B)(6) CARRIED OUT BY (B)(6):NO CONTAMINATION. (B)(6): - NEW MALFUNCTION: SAMPLE #1 RETURNED AT 453.2 NG/L TROPONIN, TROPONIN CYCLE CONTROL RETURNED AT 3.5 NG/L 2 HOURS LATER. THE REPLAY OF SAMPLE NO. 1 SHOWS A RESULT OF 2.2 NG/L . PASSAGE OF PATIENT SAMPLE ON SATURN. INFORMATION GIVEN TO ABBOTT. (B)(6): - CHANGE IN VALIDATION RULE FOR TECHNICIANS, TRANSMISSION MADE BY ATTACHED INFORMATION NOTE . ALL SAMPLES RETURNING TROPONIN > 100 NG/L WITHOUT RECENT HISTORY MUST BE RE-RUN FOR VERIFICATION. (B)(6): - NEW MALFUNCTION: FIRST RUN OF A SAMPLE WITH 199.8 NG/L TROPONIN, CHECKED (ACCORDING TO TECHNICIAN VALIDATION RULES) AT 1.6 NG/L. SECOND RUN AT 2.1 NG/L. ALL THREE RUNS WERE PERFORMED ON VENUS. (B)(6): - (B)(6). CAME WITH A LEAD SPECIALIST: THEY LOADED THE LOGS FROM THE LAST TWO MONTHS, THEN CHANGED ALL THE SATURN WASH STATIONS, EMPTIED AND BLEACHED THE NEEDLE CLEANING BUFFER TANK, AND RECHANGED THE VACUUM PUMP. - (B)(6). (ABBOTT SALES REPRESENTATIVE) AND MR. (B)(6) (CUSTOMER EXPERIENCE DIRECTOR) CAME TO SEE US: A PRIORI, THERE WAS NO APPARENT PROBLEM WITH TROPONIN IN THE OTHER (B)(6)LABORATORIES EQUIPPED BY ABBOTT. INVESTIGATIONS PLANNED WITH (B)(6) FOR THE EUROPEAN LABORATORIES. - AS A REMINDER, THE VALIDATION RULE IS MAINTAINED (REPEAT OF ALL TROPONINS > 100 NG/L WITHOUT RECENT HISTORY). THE RE-RECALL RATE HAS INCREASED FROM (B)(4) IN 2020 TO (B)(4) SINCE THIS VALIDATION RULE. (B)(6) AND MR. (B)(6) WILL MAKE ARRANGEMENTS TO COMPENSATE FOR THE EXTRA REAGENT COST AT THE END OF THE MALFUNCTION. 29/03: - MAIL FROM ABBOTT'S CUSTOMER SERVICE: OUR FILE HAS BEEN FORWARDED TO THE PRODUCT QUALITY TEAMS RESPONSIBLE FOR FURTHER INVESTIGATIONS. 30/03: - TEMPORARY WITHDRAWAL OF BARRICOR TUBES IN THE EMERGENCY ROOM. POSSIBLE MALFUNCTION DUE TO THE BARRICOR TUBES THEMSELVES OR TO THE PRE-ANALYSIS (CENTRIFUGATION PROGRAM NOT ADAPTED TO THESE TUBES). 21/APR/2021 - UPDATE: - REGARDING THE BARRICOR TUBE FILLING PROBLEM, WE USE THESE TUBES IN THE EMERGENCY DEPARTMENT THAT COLLECTS ON KT. AND IT IS LIKELY THAT, ON A SIGNIFICANT NUMBER OF SAMPLES, THE PURGE TUBE IS NOT USED. THE USE OF BARRICOR LOW-VACUUM TUBES THEREFORE DOES NOT ALLOW FOR OPTIMAL FILLING. TROPONIN MALFUNCTIONS ON "BARRICOR TUBE" HAVE BEEN FOUND ON WELL-FILLED TUBES. - WE HAVE REDUCED THE RISK FOR THE PATIENT BY CONTROLLING SINCE FEBRUARY ALL TROPONINS > 100 NG/L. ONLY 2 SAMPLES WERE RETURNED WITH AN ERRONEOUS RESULT. FOR THE OTHERS, WE HAVE MADE UP FOR THE ERROR BY SYSTEMATICALLY CHECKING THE ASSAYS BEFORE VALIDATION. THIS RESULTED IN AN INCREASE IN THE TIME REQUIRED TO RETURN THE RESULT. THE PATIENTS FOR WHOM A HIGH VALUE IS RETURNED IN THE FIRST INSTANCE ARE SUBJECT TO INCREASED SURVEILLANCE IN THE EMERGENCY ROOM, LEADING TO AN INCREASE IN THE LENGTH OF HOSPITALIZATION. WE HAVE BEEN OBLIGED TO INFORM THE CLINICIANS OF THIS FACT, ALSO CALLING ON THEM TO BE MORE VIGILANT. - REGARDING YOUR PROPOSAL TO SEND TUBES, WE THINK THAT IT IS NOT NECESSARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 705826 | TUBE PMS PLH 13X100 3.5 PLBL LIM CE | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |