BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS ARIA

    MDR report key: 11636948 · Received April 8, 2021

    Report

    Report Number
    2916837-2021-00159
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 12, 2021
    Report Date
    September 8, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GHO
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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 · 1

    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 · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530380 BD FACS ARIA NA GHO BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1