BD FACS¿ LYSE WASH ASSISTANT
Report
- Report Number
- 2916837-2024-00054
- Event Type
- Malfunction
- Date Received
- December 23, 2024
- Date of Event
- December 6, 2024
- Report Date
- February 4, 2025
- Manufacturer
- BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
- Product Code
- JQW
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INITIAL REPORTED ADDRESS: (B)(6). H3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILLED.
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. ADDITIONAL INFORMATION PROVIDED SHOWS THAT THERE WAS NO CARRYOVER BETWEEN PATIENT SAMPLES OR ANY CONTAMINATION THAT AFFECTED PATIENT RESULTS. THIS IS NOT CONSIDERED A REPORTABLE MALFUNCTION AT THIS TIME.
IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT CARRYOVER OCCURRED WITH PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CLIENT OBSERVED CONTAMINATION, BEFORE PASSING THE RESULTS, BY COMPARING THE RESULTS WITH RESULTS OF SAMPLES THAT COME FROM ANOTHER LWA.
IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT CARRYOVER OCCURRED WITH PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CLIENT OBSERVED CONTAMINATION, BEFORE PASSING THE RESULTS, BY COMPARING THE RESULTS WITH RESULTS OF SAMPLES THAT COME FROM ANOTHER LWA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2497922 | BD FACS¿ LYSE WASH ASSISTANT | STATION, PIPETTING DILUTING CLINICAL | JQW | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |