FACSLYRIC 2L6C INSTRUMENT
Report
- Report Number
- 2916837-2021-00418
- Event Type
- Malfunction
- Date Received
- October 27, 2021
- Date of Event
- September 28, 2021
- Report Date
- December 21, 2021
- Manufacturer
- BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
- Product Code
- OYE
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO FACSLYRIC 2L6C INSTRUMENT, PART # 659180, SERIAL # (B)(6) . ¿ PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING THE INSTRUMENT PRODUCING ERRONEOUS RESULTS. ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 28SEP2020 TO DATE 28SEP2021. ¿ COMPLAINT TREND: THERE ARE 2 COMPLAINTS RELATED TO THE ISSUE OF ERRONEOUS RESULTS FOR THIS PART NUMBER WITHIN THE DATE RANGE. DATE RANGE FROM 28SEP2020 TO DATE 28SEP2021. ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART #659180 SERIAL # (B)(6) , FILE #(B)(4), WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ¿ INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICEMAX, THE ROOT CAUSE OF THE ERRONEOUS RESULTS WAS DUE TO MISALIGNED OPTICS. THE CUSTOMER HAD INITIALLY REPORTED THAT THE INSTRUMENT WAS PRODUCING ERRONEOUS RESULTS. A TSR (TECHNICAL SERVICE REPRESENTATIVE) AND AS (APPLICATION SPECIALIST) ATTEMPTED TO DETERMINE THE CAUSE USING THE DATA THE CUSTOMER PROVIDED, BUT ULTIMATELY AN FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED ONSITE. THE FSE FOUND THAT THE BLUE LASER WAS INTERCEPTING THE EDGE OF THE RECEIVING OPTICAL FIBER, AND THUS THE OPTICS WERE ADJUSTED. AS A PREVENTATIVE MEASURE, THE FSE ALSO CLEANED THE FLOWCELL AND APPLIED NEW OPTICAL GEL ON THE FLOWCELL. NO PARTS WERE REQUESTED FOR EVALUATION AS THERE WERE NO PARTS REPLACED. AFTER THE REPAIR, THE INSTRUMENT WAS TESTED, THE PARAMETERS WERE CONFIRMED, AND THE INSTRUMENT WAS DETERMINED TO BE FUNCTIONING AS EXPECTED. ALTHOUGH THE INSTRUMENT WAS BEING USED FOR CLINICAL DIAGNOSES, THE RESULTS GATHERED DURING THE INCIDENT WERE NOT USED AND NO PATIENT SAMPLES WERE AFFECTED. THE RESULTS WERE CAPTURED PRIOR TO ANY DIAGNOSIS DECISION AND WAS REPORTED TO BD AS NOT EXPECTED. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(4), CASE # (B)(4). INSTALL DATE: (B)(6) 2018. DEFECTIVE PART NUMBER: N/A. WORK ORDER NOTES: O SUBJECT / REPORTED: 651165 - FACSLYRIC 2L6C INSTRUMENT - INCORRECT RESULTS. O PROBLEM DESCRIPTION: 2. IN ADDITION, WE HAVE RECENTLY NOTICED A PROBLEM WITH THE RESULTS FROM THE DEVICE (I AM ENCLOSING THE RESULTS FOR COMPARISON). O WORK PERFORMED: SYSTEM OPERATION CONTROL WITH CAB BEADS - INCREASED RCV FOR FITC WAS FOUND. THE BLUE LASER INTERCEPT POINT WAS OBSERVED AT THE EDGE OF THE RECEIVING OPTICAL FIBER AND THEN THE OPTICS WERE ADJUSTED. PREVENTIVELY, THE MEASURING CELL WAS DISASSEMBLED AND CLEANED, AND THE OPTICAL GEL BEHIND THE MEASURING CELL WAS REPLACED. THE MIRROR MOTORS OF THE LASERS WERE INITIALIZED AND THEN THE OPTICS WERE CLEANED AND ALIGNED. LO, MED AND HI FLOWS WERE CHECKED WITH TRUCOUNT TUBES - CORRECT. REMOVED FCS CYTOMETERSETUP FILES FROM C: \ PROGRAMDATA \ BD \ FACSUITE \ LOGS \ SERIALNUMBER \ SETUP \ 4-BLUE 2-RED \ FCSFILES \ CYTOMETERSETUP OCCUPYING MORE THAN 35GB ON THE DISK. THE EVENT LOG FROM EMBEDED PC HAS BEEN DOWNLOADED AND DELETED. CQC CHARACTERIZATION WAS PERFORMED - NORMAL RESULTS. ABORT COUNT PARAMETER CHECKED - CORRECT RESULT. THE DEVICE IS TECHNICALLY EFFICIENT, INSPECTION ACCORDING TO THE SCHEDULE. O CAUSE: DETUNED OPTICS. O SOLUTION: OPTICS ADJUSTMENT. INTERNAL NOTES: O (10/18/2021) FSE ASKED TO DISPATCH THE WO. O (10/14/2021) USER WILL OBSERVE THE INSTRUMENT. O (10/11/2021) ACCORDING TO APP SPECIALIST - THE NEEDLE NEEDS TO BE CLEANED MORE OFTEN AFTER MEASUREMENTS - AND THE USER HAS TO OBSERVE THE INSTRUMENT. O (9/30/2021) PROBABLY QUOTE FOR DIAGNOSTIC VISIT IS NEEDED. O (9/30/2021) ISSUE WAS RAISED ON BDB MEETING, IN OPINION OF FSE THE INSTRUMENT NEED TO BE CHECKED. O (9/29/2021) APP SPECIALIST WAS ASKED FOR OPINION. O (9/29/2021) FILTERS WERE EXCHANGED ON 24/08. O (9/29/2021) PQC LOOKS FINE, ASKED USER TO EXCHANGE THE FILTER SINCE THE OLD ONE BECAUSE DID NOT EXCHANGE SINCE 11/2020. O (9/29/2021) 2. NOT EVERY MEASUREMENT LOOKS LIKE THIS. THIS IS A LOTTERY: ONE RESULT IS CORRECT, ANOTHER IS INCORRECT. IN SUCH SITUATIONS, RINSING THE DEVICE SEVERAL TIMES HELPS. THE RESULTS OF TODAY'S PQC ARE ATTACHED. I'M NOT SURE, BUT IT SEEMS TO ME THAT THE FILTERS WERE REPLACED DURING THE LAST REVIEW, I.E. 11.2020. MONTHLY WASHING WAS DONE AT THE END OF AUGUST. I GOT INFORMATION THAT DOING SUCH A WASHING DOES NOT HELP. ANOTHER MEASUREMENT AFTER SUCH WASHING MAY BE INCORRECT. O (9/28/2021) 2. DOES EACH MEASUREMENT LOOK LIKE THIS? PLEASE SUBMIT THE LAST PQC, AND PREFERABLY PERFORM A PQC WHEN SUCH MEASUREMENTS ARE AVAILABLE. WHEN WAS THE LAST TIME YOU REPLACED THE FILTER AND WHEN WAS THE LAST TIME YOU HAD A MONTHLY WASH? THANKS IN ADVANCE FOR ANY ADDITIONAL INFORMATION. ¿ RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE NO PARTS WERE REPLACED. ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART # 10000063058RA, REV. 03/VERS. I, LIBERTY PROGRAM BD FACSLYRIC SYSTEM RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATIONS ARE SUFFICIENT. HAZARD(S) IDENTIFIED? YES NO. O TFS ID: 89321. O ID: LIBIVD-RA-395 3.1.119. O REG STATUS: IVD; RUO. O HAZARD: LOSS SAMPLE AND TIME. O CAUSE: LASER OUT OF ALIGNMENT. LASER BEAM DRIFTED FROM THE SAMPLE STREAM. USER NOTICED PEAKS WIDEN. O HARMFUL EFFECTS: INCORRECT RESULTS. O RISK CONTROL: DAILY PQC WILL DETECT THE LASER OUT OF ALIGNMENT. FACSUITE CLINICAL SOFTWARE OR THE FACSUITE SOFTWARE SHALL ALLOW THE USER TO PERFORM LASER ALIGNMENT, WHEN %RCV ACCEPTANCE CRITERIA ARE NOT MET. O REQ LINK (TFS ID): 92215 FS11-DID-7127 AUTO-LASER ALIGNMENT. 92216 FS11-DID-7131 AUTO-LASER ALIGNMENT. O IMPLEMENTATION VERIFICATION: LIBIVD-15-04P. O EFFECTIVENESS VERIFICATION: LIBIVD-15-04F. O PROBABILITY: 1. O SEVERITY: 3. O RISK INDEX: 3. O RESIDUAL RISK EVALUATION: A. O NEW HAZARDS: NONE. MITIGATION(S) SUFFICIENT YES NO. ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE ERRONEOUS RESULTS WAS DUE TO MISALIGNED OPTICS. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE ERRONEOUS RESULTS WAS DUE TO MISALIGNED OPTICS. THE FSE CONFIRMED THE ISSUE AND REALIGNED THE OPTICAL PATH. AS A PREVENTATIVE MEASURE, THE FLOWCELL WAS CLEANED AND NEW OPTICAL GEL WAS APPLIED. AFTER THE REPAIR, THE INSTRUMENT WAS REBOOTED, TESTED, AND FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY.
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 THERE WERE ERRONEOUS RESULTS WHILE USING FACSLYRIC 2L6C INSTRUMENT. THESE ARE RELATED TO IVD INSTRUMENT HARDWARE, IVD/ASR REAGENT, AND RUO LDT REAGENT. IT IS UNCLEAR WHETHER THE ERRONEOUS RESULTS WERE CAUSED FROM AN RUO REAGENT, OR A COMBINATION OF IVD OR RUO REAGENTS, OR THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2. IN ADDITION, WE HAVE RECENTLY NOTICED A PROBLEM WITH THE RESULTS FROM THE DEVICE.
IT WAS REPORTED THAT THERE WERE ERRONEOUS RESULTS WHILE USING FACSLYRIC 2L6C INSTRUMENT. THESE ARE RELATED TO IVD INSTRUMENT HARDWARE, IVD/ASR REAGENT, AND RUO LDT REAGENT. IT IS UNCLEAR WHETHER THE ERRONEOUS RESULTS WERE CAUSED FROM AN RUO REAGENT, OR A COMBINATION OF IVD OR RUO REAGENTS, OR THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2. IN ADDITION, WE HAVE RECENTLY NOTICED A PROBLEM WITH THE RESULTS FROM THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1606333 | FACSLYRIC 2L6C INSTRUMENT | NA | OYE | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |