BD FACSVIA¿ FLOW CYTOMETER
Received Oct 20, 2023 · Event occurred Sep 25, 2023
Report 2916837-2023-00203 · MDR key 17981572
Device
Generic name
Flow Cytometric Reagents And Accs
Manufacturer
Becton Dickinson And Company Bd BiosciencesCatalog number
656874
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
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE (B)(4). INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE IMPROPER HLA RESULTS WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE POTENTIAL CAUSE FOR IMPROPER HLA RESULTS WAS A DIRTY FLOWCELL. THE CUSTOMER REPORTED A COMPLAINT REGARDING IMPROPER HLA RESULTS. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED A SERVICE VISIT AND CLEANED THE FLOWCELL AND SAMPLE INJECTION PROBE (SIP). AFTER THE CLEANING, THE SAMPLES WERE RUN, AND THE RESULTS WERE ACCEPTABLE. AFTER THE WORKS PERFORMED, THE INSTRUMENT WAS PERFORMING AS INTENDED. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT BD FACSVIA¿ FLOW CYTOMETER ERRONEOUS RESULTS WERE OBTAINED FOR PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HLA RESULTS NOT PROPER. 1) ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? - YES. 2) WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? - NO.
Additional Manufacturer Narrative
INITIAL REPORTER ADDRESS: (B)(6) H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT BD FACSVIA¿ FLOW CYTOMETER ERRONEOUS RESULTS WERE OBTAINED FOR PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HLA RESULTS NOT PROPER 1) ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? - YES 2) WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? - NO