BD FACS¿ LYSE WASH ASSISTANT
Received Apr 22, 2025 · Event occurred Apr 1, 2025
Report 3027394506-2025-00017 · MDR key 21881388
Device
Generic name
Station, Pipetting Diluting Clinical Use
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
337146
Product problems
- Contamination
- Contamination
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 DURING USE WITH BD FACS¿ LYSE WASH ASSISTANT CARRYOVER OCCURRED ON PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: CARRYING OUT IN-DEPTH TESTING OF THE INSTRUMENT'S PROPER FUNCTIONING CONTAMINATION - CARRY OVER.
Additional Manufacturer Narrative
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative
BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF THE CUSTOMER EXPERIENCING CARRYOVER WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: - THE COMPLAINT TREND AND SERVICE NOTES WERE REVIEWED. - DEVICE HISTORY RECORD (DHR) REVIEWED. - THE POTENTIAL CAUSE FOR THE CUSTOMER EXPERIENCING CARRYOVER COULD NOT BE DETERMINED. 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.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH BD FACS¿ LYSE WASH ASSISTANT CARRYOVER OCCURRED ON PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: CARRYING OUT IN-DEPTH TESTING OF THE INSTRUMENT'S PROPER FUNCTIONING CONTAMINATION - CARRY OVER.