BD FACSLYRIC¿ 3L10C INSTRUMENT
Received Sep 28, 2023 · Event occurred Sep 1, 2023
Report 2916837-2023-00186 · MDR key 17839575
Device
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 WHILE USING BD FACSLYRIC? FLOW CYTOMETER AN ERROR MESSAGE OCCURRED DURING DIAGNOSTIC TESTING THAT DOES NOT ALLOW THE USER TO PROCEED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TAKING INTO ACCOUNT THAT THIS IS LABORATORY AND THE INSTRUMENT IS IVD I CAN ASSUME THEY RAN PATIENT SAMPLES. THE ERROR MESSAGE THOUGH HAS NOTHING TO DO WITH ANY MEASUREMENT NOR WITH THE PERFORMANCE OF INSTRUMENT, SO THE MEASUREMENTS WERE FINE. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): UNKNOWN. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? (IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. IS THIS PRESTO? (EITHER YES OR NO, NO FURTHER QUESTIONS REQUIRED): NO.
Additional Manufacturer Narrative
INITIAL REPORTER PHONE: (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.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE - (B)(6). AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. THIS WAS A SOFTWARE ERROR FOR EXPORTS, ALSO FOLLOW UP SHOWED THAT THIS DID NOT IMPACT PATIENT SAMPLE TESTING, THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD FACSLYRIC? FLOW CYTOMETER AN ERROR MESSAGE OCCURRED DURING DIAGNOSTIC TESTING THAT DOES NOT ALLOW THE USER TO PROCEED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TAKING INTO ACCOUNT THAT THIS IS LABORATORY AND THE INSTRUMENT IS IVD I CAN ASSUME THEY RAN PATIENT SAMPLES. THE ERROR MESSAGE THOUGH HAS NOTHING TO DO WITH ANY MEASUREMENT NOR WITH THE PERFORMANCE OF INSTRUMENT, SO THE MEASUREMENTS WERE FINE. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): UNKNOWN. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? (IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. IS THIS PRESTO? (EITHER YES OR NO, NO FURTHER QUESTIONS REQUIRED): NO.