BD FACSCALIBUR¿ 4 CLR BASIC SENSOR UNIT
Received Nov 2, 2023 · Event occurred Oct 16, 2023
Report 2916837-2023-00212 · MDR key 18056648
Device
Generic name
Counter, Differential Cell
Manufacturer
Becton Dickinson And Company Bd BiosciencesCatalog number
343202
Lot number
NA
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 - (B)(6). H.6 INVESTIGATION SUMMARY: BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS, AND SERVICE ACTIVITY REVIEW THE COMPLAINT WAS CONFIRMED, AND THE POTENTIAL CAUSE OF INCORRECT ABSOLUTE COUNTS WAS DETERMINED TO BE WORN OUT PMT AND SOCKETS. IN RESPONSE TO THE CUSTOMER COMPLAINT FSE VISITED ONSITE AND REPLACED PMT AND SOCKETS AFTER TROUBLESHOOTING TESTS. SUBSEQUENT CST SHOWED THAT THE INSTRUMENT IS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. 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 DURING USE WITH BD FACSCALIBUR¿ 4 CLR BASIC SENSOR UNIT ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THE EQUIPMENT IS GIVING INCORRECT ABSOLUTE COUNTS. 1. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? YES.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH BD FACSCALIBUR¿ 4 CLR BASIC SENSOR UNIT ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THE EQUIPMENT IS GIVING INCORRECT ABSOLUTE COUNTS. 1. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? YES.
Additional Manufacturer Narrative
D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.