BD FACSCANTO¿ II
Received Oct 10, 2023 · Event occurred Sep 29, 2023
Report 2916837-2023-00194 · MDR key 17906537
Device
Generic name
Counter, Differential Cell
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
338962
Lot number
NA
Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2916837-2023-00194 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED BY THAT ERROR MESSAGES WERE BYPASSED AND TESTING WAS ABLE TO CONTINUE DURING USE WITH THE BD FACSCANTO¿ II. CUSTOMER USED A DIFFERENT MODE (SINGLE TUBE MODE) OF TESTING SAMPLES. 16OCT2023 RECEIVED EMAIL (ATTACHED) FROM CTS: HELLO, THE CANTO/CANTO10/CANTO II HAS THE ABILITY TO RUN WITH THE CAROUSEL/LOADER OR IN SINGLE TUBE MODE. IN THIS INSTANCE, THE CUSTOMER BYPASSED THIS PARTICULAR ERROR MESSAGE FOR THE CAROUSEL/LOADER AND RAN IN SINGLE TUBE MODE. I HOPE THIS HELP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDR SAFETY CHECKLIST - ERROR MESSAGES (CASE) 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? (IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 4.IS THIS PRESTO? NO. IT WAS REPORTED BY THE CUSTOMER THAT TUBE GUIDE NOT IN PLACE ERROR. TUBE GUIDE NOT IN PLACE ERROR.
Additional Manufacturer Narrative
D.4. MEDICAL DEVICE EXPIRATION DATE: NA. E.1. INITIAL REPORTER ADDRESS 1: (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 BY THAT ERROR MESSAGES WERE BYPASSED AND TESTING WAS ABLE TO CONTINUE DURING USE WITH THE BD FACSCANTO¿ II. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDR SAFETY CHECKLIST - ERROR MESSAGES (CASE). ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 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? NO. IT WAS REPORTED BY THE CUSTOMER THAT TUBE GUIDE NOT IN PLACE ERROR. TUBE GUIDE NOT IN PLACE ERROR.