BD FACSDUET¿ SAMPLE PREP
Received Oct 24, 2023 · Event occurred Sep 21, 2023
Report 2916837-2023-00205 · MDR key 17996300
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
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 WAS SENT IN ERROR. THE FSE HAS REPORTED THAT THERE WERE NO ERRONEOUS RESULTS, ISSUE IS AN INSTRUMENT ERROR, THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD FACSDUET¿ SAMPLE PREP HAS NOT PROCESSED SAMPLES CORRECTLY AND HAS NOT DISPENSED ALL THE REAGENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOR SOME DAYS THE PREPARER HAS NOT PROCESSED THE SAMPLES CORRECTLY AND HAS NOT DISPENSED ALL THE REAGENTS. THE PROBLEM IS MAINLY FOUND WITH THE LYSANT. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): NO.
Additional Manufacturer Narrative
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 WHILE USING BD FACSDUET¿ SAMPLE PREP HAS NOT PROCESSED SAMPLES CORRECTLY AND HAS NOT DISPENSED ALL THE REAGENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOR SOME DAYS THE PREPARER HAS NOT PROCESSED THE SAMPLES CORRECTLY AND HAS NOT DISPENSED ALL THE REAGENTS. THE PROBLEM IS MAINLY FOUND WITH THE LYSANT. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): NO.