BD FACS ARIA
Received Apr 8, 2021 · Event occurred Mar 12, 2021
Report 2916837-2021-00159 · MDR key 11636948
Device
Generic name
Na
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
643177
Lot number
NA
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AFTER FURTHER REVIEW MFR# 2916837-2021-00159 IS NO LONGER REPORTABLE. THIS DEVICE IS FOR RESEARCH USE ONLY AND IS NOT BEING USED FOR DIAGNOSTIC TESTING OR PATIENT TREATMENT AND IS THEREFORE NOT SUBJECT TO MDR REPORTING.
Description of Event or Problem
IT WAS REPORTED WHILE TESTING WITH BD FACS ARIA¿ ERRONEOUS RESULTS WERE OBTAINED ON PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, GO TO QUESTION #2, IF NO, NO FURTHER QUESTIONS REQUIRED.) 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3) 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4) 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED) 5. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUESTION #6) 6. WHAT IS THE CURRENT MEDICAL STATUS? (NO FURTHER QUESTIONS REQUIRED.) ANSWERS TRANSLATED FROM CHINESE TO ENGLISH USING GOOGLE: 1. YES. 2. NO. 3. NO. 4. NO. 5. BLANK. 6. BLANK. ADDITIONALLY, ON 2021-03-12 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: 1. FACSARIA II-THE FLUID FLOW IS UNSTABLE, CAUSING ABNORMAL IMAGE RESULTS, USING HUMAN PERIPHERAL BLOOD SPECIMENS 2. CLINICAL USE.
Additional Manufacturer Narrative
MEDICAL DEVICE EXPIRATION DATE: NA. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
Description of Event or Problem
IT WAS REPORTED WHILE TESTING WITH BD FACS ARIA¿ ERRONEOUS RESULTS WERE OBTAINED ON PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, GO TO QUESTION #2, IF NO, NO FURTHER QUESTIONS REQUIRED.). WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3). IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4). WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED). PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUESTION #6). WHAT IS THE CURRENT MEDICAL STATUS? (NO FURTHER QUESTIONS REQUIRED.). ANSWERS TRANSLATED FROM (B)(6) TO ENGLISH USING GOOGLE: YES, NO, NO, NO, BLANK, BLANK. ADDITIONALLY, ON (B)(6) 2021 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: FACSARIA II-THE FLUID FLOW IS UNSTABLE, CAUSING ABNORMAL IMAGE RESULTS, USING HUMAN PERIPHERAL BLOOD SPECIMENS. CLINICAL USE.