BD FACS¿ LYSE WASH ASSISTANT
Received Jul 10, 2024 · Event occurred Jun 12, 2024
Report 2916837-2024-00040 · MDR key 19714174
Device
Generic name
Station, Pipetting Diluting Clinical Use
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
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT CARRYOVER OCCURRED BETWEEN PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED CONTAMINATION ISSUES: CELLS ARE TRANSFERRED FROM ONE TUBE TO THE NEXT. THIS COULD LEAD TO MISS INTERPRETATION OF THE RESULTS 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? CARRYOVER BETWEEN PATIENT SAMPLES.
Additional Manufacturer Narrative
H6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, COMPLAINT WAS NOT CONFIRMED, AND THE POTENTIAL CAUSE COULD NOT BE DETERMINED. THE CUSTOMER REPORTED A COMPLAINT REGARDING CONTAMINATION. THEY REPORTED THAT CELLS FROM ONE TUBE ARE TRANSFERRED TO THE NEXT TUBE. THE POTENTIAL CAUSE COULD NOT BE DETERMINED. THE APPLICATION DEPARTMENT PERFORMED ON-SITE TESTS AND VERIFIED THAT THE INSTRUMENT IS COMPLIANT AND DOES NOT PRESENT ANY CARRYOVER OUTSIDE OF BD SPECIFICATION. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS IDENTIFIED AND RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT. NEITHER THE CUSTOMER NOR ANY PATIENTS WERE HARMED DUE TO THIS ISSUE.
Additional Manufacturer Narrative
H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT CARRYOVER OCCURRED BETWEEN PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED CONTAMINATION ISSUES: CELLS ARE TRANSFERRED FROM ONE TUBE TO THE NEXT. THIS COULD LEAD TO MISS INTERPRETATION OF THE RESULTS 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? CARRYOVER BETWEEN PATIENT SAMPLES.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED: D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H.6 - IMDRF ANNEX B CODE-B21; H.6 - IMDRF ANNEX C CODE-C21; H.6 - IMDRF ANNEX D CODE-D16.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT CARRYOVER OCCURRED BETWEEN PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED CONTAMINATION ISSUES: CELLS ARE TRANSFERRED FROM ONE TUBE TO THE NEXT. THIS COULD LEAD TO MISS INTERPRETATION OF THE RESULTS. 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? CARRYOVER BETWEEN PATIENT SAMPLES.