BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD

Additional Manufacturer Narrative

D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER FACILITY NAME: (B)(6). H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT LIQUID LEAKAGE OCCURRED ON BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD AND CAUSED ERRONEOUS PATIENT SAMPLE RESULTS. NO PATIENT TREATMENT DELAY WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIQUID LEAKAGE IN HYDRAULIC SYSTEM. ARE THERE ERRONEOUS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES.

Additional Manufacturer Narrative

THIS CORRECTION REPORT IS BEING SENT TO CORRECT THE PREVIOUSLY SUBMITTED REPORT 2916837-2024-00010 FOR THE FOLLOWING FIELDS: TYPE OF REPORTABLE EVENTS: MALFUNCTION.

Description of Event or Problem

IT WAS REPORTED THAT LIQUID LEAKAGE OCCURRED ON BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD AND CAUSED ERRONEOUS PATIENT SAMPLE RESULTS. NO PATIENT TREATMENT DELAY WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIQUID LEAKAGE IN HYDRAULIC SYSTEM. ARE THERE ERRONEOUS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES.

Additional Manufacturer Narrative

AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2916837-2024-00010 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 THAT LIQUID LEAKAGE OCCURRED ON BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD AND CAUSED ERRONEOUS PATIENT SAMPLE RESULTS. NO PATIENT TREATMENT DELAY WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIQUID LEAKAGE IN HYDRAULIC SYSTEM ARE THERE ERRONEOUS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES