BD FACS¿ LYSE WASH ASSISTANT
Received Dec 23, 2024 · Event occurred Dec 6, 2024
Report 2916837-2024-00054 · MDR key 21009514
Device
Generic name
Station, Pipetting Diluting Clinical
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
337146
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
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.
Description of Event or Problem
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.
Additional Manufacturer Narrative
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.