inforMED
MalfunctionPER

BD FACSDUET¿ SAMPLE PREP

Received Aug 21, 2024 · Event occurred Jul 8, 2024

Report 2916837-2024-00045 · MDR key 20010307

Device

Generic name

Station, Pipetting Diluting Clinical Use

Catalog number

666340

Product problems

  • Improper or Incorrect Procedure or Method
  • Improper or Incorrect Procedure or Method

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSDUET USER BYPASSED ERROR MESSAGE. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED BY THE CUSTOMER THAT ASPIRATION ERRORS. 1. IS THIS FACSPRESTO OR FACSCOUNT? IF YES, NO FURTHER QUESTIONS REQUIRED. IF NO, GO TO QUESTION #2.: NO. 2. DID THE INSTRUMENT DISPLAY AN ERROR MESSAGE? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.: YES. 3. WHAT ERROR MESSAGE WAS DISPLAYED? (PROVIDE ERROR CODE AND/OR DESCRIPTION) GO TO QUESTION #4.: ERROR DISPENSING LYSE. 4. DID YOU RUN A DIAGNOSTIC PATIENT ASSAY WITHOUT RESOLVING THE ERROR MESSAGE? IF NO, NO FURTHER QUESTIONS REQUIRED. IF YES, GO TO QUESTION #5 AND THEN GO TO PATIENT SAMPLES CHECKLIST.: YES.

Additional Manufacturer Narrative

H.11 - AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. FURTHER INFORMATION HAS BEEN OBTAINED AND THE CUSTOMER DID NOT BYPASS THE ERROR MESSAGE, THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSDUET USER BYPASSED ERROR MESSAGE. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED BY THE CUSTOMER THAT ASPIRATION ERRORS. 1. IS THIS FACSPRESTO OR FACSCOUNT? IF YES, NO FURTHER QUESTIONS REQUIRED. IF NO, GO TO QUESTION #2.: NO. 2. DID THE INSTRUMENT DISPLAY AN ERROR MESSAGE? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.: YES. 3. WHAT ERROR MESSAGE WAS DISPLAYED? (PROVIDE ERROR CODE AND/OR DESCRIPTION) GO TO QUESTION #4.: ERROR DISPENSING LYSE. 4. DID YOU RUN A DIAGNOSTIC PATIENT ASSAY WITHOUT RESOLVING THE ERROR MESSAGE? IF NO, NO FURTHER QUESTIONS REQUIRED. IF YES, GO TO QUESTION #5 AND THEN GO TO PATIENT SAMPLES CHECKLIST.: YES.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION. H.6 IMDRF ANNEX: B21. H.6 IMDRF ANNEX: C21. H.6 IMDRF ANNEX: D16.

Additional Manufacturer Narrative

D.4. MEDICAL DEVICE EXPIRATION DATE: NA H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. G.5. PMA / 510(K)#: NA

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSDUET USER BYPASSED ERROR MESSAGE. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED BY THE CUSTOMER THAT ASPIRATION ERRORS. 1. IS THIS FACSPRESTO OR FACSCOUNT? IF YES, NO FURTHER QUESTIONS REQUIRED. IF NO, GO TO QUESTION #2.: NO 2. DID THE INSTRUMENT DISPLAY AN ERROR MESSAGE? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.: YES 3. WHAT ERROR MESSAGE WAS DISPLAYED? (PROVIDE ERROR CODE AND/OR DESCRIPTION) GO TO QUESTION #4.: ERROR DISPENSING LYSE. 4. DID YOU RUN A DIAGNOSTIC PATIENT ASSAY WITHOUT RESOLVING THE ERROR MESSAGE? IF NO, NO FURTHER QUESTIONS REQUIRED. IF YES, GO TO QUESTION #5 AND THEN GO TO PATIENT SAMPLES CHECKLIST.: YES