BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
Report
- Report Number
- 2916837-2024-00031
- Event Type
- Malfunction
- Date Received
- May 20, 2024
- Date of Event
- April 25, 2024
- Report Date
- January 30, 2025
- Manufacturer
- BECTON DICKINSON AND COMPANY BD BIOSCIENCES
- Product Code
- GKZ
- UDI-DI
- 00382903403349
- PMA / PMN Number
- K090967
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: MEDICAL DEVICE TYPE: OYE COMMON DEVICE NAME: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES ADDITIONAL PMA / 510(K)#: K170974 , K950057 , K970326 , K970742 , K970836, K971110 , K971205 , K980858 A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6: BASED ON THE INVESTIGATION RESULTS, THE REPORTED DEFECT WAS CONFIRMED, HOWEVER WAS NOT REPLICATED AFTER RETAIN SAMPLE TESTING. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: -BATCH HISTORY RECORD (BHR) REVIEW A SHOWING ACCEPTABLE PERFORMANCE. -RETAIN SAMPLE TESTING SHOWING ACCEPTABLE PERFORMANCE. -REVIEW OF CUSTOMER PROVIDED INFORMATION. -POTENTIAL CAUSE FOR CUSTOMER REPORTED COMPLAINT WAS NOT DETERMINED. - FOR RESOLUTION THE CUSTOMER WAS REFERRED TO SCIENTIFIC SUPPORT. 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.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: H.6 IMDRF ANNEX B: B21, H.6 IMDRF ANNEX C: C21, H.6 IMDRF ANNEX D: D16.
IT WAS REPORTED THAT DURING USE WITH BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES ERRONEOUS RESULTS WERE OBTAINED AND REPORTED TO CLINICIAN. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DIFFERENCES APPEARED IN ABSOLUTE VALUES BETWEEN TWO CYCLOMETERS ON THE SAME SAMPLE ID THE CUSTOMER SAID SHE IS OBLIGED TO INITIATE AN OFFICIAL COMPLAINT TO HEALTH AUTHORITIES.
IT WAS REPORTED THAT DURING USE WITH BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES ERRONEOUS RESULTS WERE OBTAINED AND REPORTED TO CLINICIAN. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DIFFERENCES APPEARED IN ABSOLUTE VALUES BETWEEN TWO CYCLOMETERS ON THE SAME SAMPLE ID THE CUSTOMER SAID SHE IS OBLIGED TO INITIATE AN OFFICIAL COMPLAINT TO HEALTH AUTHORITIES.
IT WAS REPORTED THAT DURING USE WITH BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES ERRONEOUS RESULTS WERE OBTAINED AND REPORTED TO CLINICIAN. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DIFFERENCES APPEARED IN ABSOLUTE VALUES BETWEEN TWO CYCLOMETERS ON THE SAME SAMPLE ID THE CUSTOMER SAID SHE IS OBLIGED TO INITIATE AN OFFICIAL COMPLAINT TO HEALTH AUTHORITIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1605716 | BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES | COUNTER, DIFFERENTIAL CELL | GKZ | BECTON DICKINSON AND COMPANY BD BIOSCIENCES | UNKNOWN | 00382903403349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |