BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD
Received Oct 23, 2023 · Event occurred Oct 3, 2023
Report 2916837-2023-00204 · MDR key 17991315
Device
Generic name
Counter, Differential Cell
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
338960
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD SENSOR ERROR CAME ON WHILE RUNNING PATIENT SAMPLES AND ERROR WAS BYPASSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASTE SENSOR ERROR. 1.ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? ANS. YES. 2. WAS THERE AN ERROR MESSAGE?. ANS. YES. 3.DID THE CUSTOMER BYPASS THE ERROR MESSAGE? ANS. YES. 4.IS THIS PRESTO? ANS. NO.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD SENSOR ERROR CAME ON WHILE RUNNING PATIENT SAMPLES AND ERROR WAS BYPASSED. G.1 - REPORTING OFFICE - (B)(6). H.6 IMDRF ANNEX F CODE: F26. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF A WASTE SENSOR ERROR WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE COMPLAINT TREND AND SERVICE NOTES WERE REVIEWED. THE POTENTIAL CAUSE FOR A WASTE SENSOR ERROR WAS DUE TO A WORN WASTE SENSOR. THE ISSUE WAS RESOLVED AFTER THE PART WAS REPLACED. NO FURTHER PROBLEMS WERE NOTED AND THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
Additional Manufacturer Narrative
(B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD SENSOR ERROR CAME ON WHILE RUNNING PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASTE SENSOR ERROR 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? ANS. YES .2. WAS THERE AN ERROR MESSAGE? ANS. YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? ANS. YES.. 4. IS THIS PRESTO? ANS. NO.