N
Patient 0
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
MAUDE MDR 24277294
- MDR report key
- 24277294
- Report number
- 3027394506-2026-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2026-01-28
- Date received
- 2026-02-06
- Adverse event
- 0
- Product problem
- 1
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 1
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- BDX FAHMY RAZAK - MDR
- Address
- 155 NORTH MCCARTHY BOULEVARD MILPITAS CA 95035 US
- Phone
- 877-877-8772
- Report source
- M
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 299171 | BD FACS? SAMPLE PREP ASSISTANT III | AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTO | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES | PER | 647205 | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2026-02-06 | 0 |
Event Narratives#
D
Patient 0
IT WAS REPORTED THAT DURING USE OF BD FACS? SAMPLE PREP ASSISTANT III, FOREIGN MATTER/CONTAMINATION IN INSTRUMENT THAT IMPACTED PATIENT RESULTS WAS OBSERVED. CONTAMINANT IS IN A POSITION WHERE IT IMPACTED A READOUT TO BE USED CLINICALLY. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT SAMPLES NOT BEING PROCESSED CORRECT. CUSTOMER REPLACED SYRINGE BUT ISSUE PERSISTS. PATIENT SAMPLES CHECKLIST: 1. DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? IF YES, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED. YES. 2. WAS AN ERRONEOUS LABORATORY RESULT FROM THE BDB PRODUCT REPORTED TO A CLINICIAN? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED. NO. CONTAMINATION: 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2. PATIENT SAMPLES CONTAMINATED. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. SAMPLES WERE NOT PROPERLY PROCESSED AND THERE WAS A RED TINGE (BLOOD) TO THE COMPLETED SAMPLES. CUSTOMER IDENTIFIED THIS IS NOT CORRECT SO THEY STOPPED USING SYSTEM. CUSTOMER THEN MANUALLY PROCESSED SAMPLES BY HAND.
D
Patient 0
IT WAS REPORTED THAT DURING USE OF BD FACS? SAMPLE PREP ASSISTANT III, FOREIGN MATTER/CONTAMINATION IN INSTRUMENT THAT IMPACTED PATIENT RESULTS WAS OBSERVED. CONTAMINANT IS IN A POSITION WHERE IT IMPACTED A READOUT TO BE USED CLINICALLY. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT SAMPLES NOT BEING PROCESSED CORRECT. CUSTOMER REPLACED SYRINGE BUT ISSUE PERSISTS. PATIENT SAMPLES CHECKLIST: 1. DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? IF YES, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED. YES. 2. WAS AN ERRONEOUS LABORATORY RESULT FROM THE BDB PRODUCT REPORTED TO A CLINICIAN? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED. NO. CONTAMINATION: 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2. PATIENT SAMPLES CONTAMINATED 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. SAMPLES WERE NOT PROPERLY PROCESSED AND THERE WAS A RED TINGE (BLOOD) TO THE COMPLETED SAMPLES. CUSTOMER IDENTIFIED THIS IS NOT CORRECT SO THEY STOPPED USING SYSTEM. CUSTOMER THEN MANUALLY PROCESSED SAMPLES BY HAND.
N
Patient 0
THE FOLLOWING FIELD WAS UPDATED WITH CORRECTED INFORMATION: H.6 IMDRF ANNEX G: G04135 VALVE(S). H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF THE CUSTOMER EXPERIENCING SAMPLES NOT BEING PROCESSED AFTER TESTING WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE COMPLAINT TREND AND SERVICE NOTES WERE REVIEWED. THE POTENTIAL CAUSE FOR THE CUSTOMER EXPERIENCING SAMPLES NOT BEING PROCESSED WAS LINKED TO THE 4-WAY VALVE. THE ISSUE WAS RESOLVED AFTER THE PART WAS REPLACED. THE REPLACED PART WAS NOT RETURNABLE; THEREFORE, IT WAS DISCARDED. NO FURTHER PROBLEMS WERE NOTED, AND THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT.