BD FACSCANTO¿ II

Description of Event or Problem

COULD YOU PLEASE VERIFY - ERROR MESSAGE WAS OBSERVED BY THE USER DURING LONG CLEAN OF THE INSTRUMENT. DID THE CUSTOMER BYPASSED THE ERROR MESSAGE AND TESTED PATIENT SAMPLE? "YES, ERROR DURING LONG CLEAN. BUT OTHERWISE THE INSTRUMENT WAS STILL USED FOR SAMPLES AS NORMAL. LONG CLEAN DID NOT PREVENT OTHER NORMAL OPERATION OF THE INSTRUMENT." USER WAS NOT TESTING PATIENT SAMPLE DURING LONG CLEAN PROCESS. IT WAS REPORTED THAT ERROR MESSAGES WERE BYPASSED AND TESTING CONTINUED DURING USE WITH THE BD FACSCANTO¿ II. 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 FLUIDIC BOARD REQUESTING SHUTDOWN - FLOAT SWITCH TIMEOUT DURING A LONG CLEAN. FLUIDIC BOARD REQUESTING SHUTDOWN - FLOAT SWITCH TIMEOUT DURING A LONG CLEAN.

Additional Manufacturer Narrative

AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2916837-2023-00193 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. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem

IT WAS REPORTED THAT ERROR MESSAGES WERE BYPASSED AND TESTING CONTINUED DURING USE WITH THE BD FACSCANTO¿ II. 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 FLUIDIC BOARD REQUESTING SHUTDOWN - FLOAT SWITCH TIMEOUT DURING A LONG CLEAN. FLUIDIC BOARD REQUESTING SHUTDOWN - FLOAT SWITCH TIMEOUT DURING A LONG CLEAN.

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.