BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
Report
- Report Number
- 2916837-2023-00223
- Event Type
- Malfunction
- Date Received
- November 30, 2023
- Date of Event
- October 5, 2023
- Report Date
- March 25, 2024
- Manufacturer
- BECTON DICKINSON AND COMPANY BD BIOSCIENCES
- Product Code
- GKZ
- UDI-DI
- 00382906630285
- PMA / PMN Number
- K090967
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE CONTACT - FAHMY RAZAK MDR. G.1 - MANUFACTURING SITE CONTACT - FAHMY RAZAK MDR. H.6: INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF HALF OF THE SAMPLES HAVING INSUFFICIENT BEAD NUMBER, WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE BATCH HISTORY RECORD (BHR) WAS REVIEWED AND THE PRODUCT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE INCLUDING BEAD COUNT TEST PARAMETERS. RETAIN SAMPLE ANALYSIS WAS EVALUATED AND RESULTS FOR THE BEAD COUNT WERE ACCEPTABLE, MEETING STANDARD DEVIATION AND %CV CRITERIA. THE POTENTIAL CAUSE WAS NOT DETERMINED, AND THE ISSUE WAS RESOLVED ONCE ANOTHER BEAD LOT WAS USED. CONDITIONS THAT MIGHT PRODUCE THE REPORTED DEFECT ARE BROKEN PELLETS, INADEQUATE STORAGE OF TUBES, AND PROLONGED EXPOSURE OF TUBES TO THE ENVIRONMENT. 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.
H10 - G.5. ADDITIONAL PMA / 510(K)#: K980858, K971205, K971110, K970326, K970742, K071143. E.1. INITIAL REPORTER FACILITY NAME: (B)(6). H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES WAS UNABLE TO DISPLAY ALL KNOWN TRUCOUNT BEADS DURING IVD TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOR HALF OF SAMPLES INSUFFICIENT BEAD NUMBER WAS ACQUIRED FOR THE TRUCOUNT BEADS LOT 22103. THIS WAS OBSERVED ON FACSCANTOII AND FACSCALIBUR INSTRUMENTS. NO PROBLEM DETECTED ONCE ANOTHER BEAD LOT WAS USED."
IT WAS REPORTED THAT BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES WAS UNABLE TO DISPLAY ALL KNOWN TRUCOUNT BEADS DURING IVD TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOR HALF OF SAMPLES INSUFFICIENT BEAD NUMBER WAS ACQUIRED FOR THE TRUCOUNT BEADS LOT 22103. THIS WAS OBSERVED ON FACSCANTOII AND FACSCALIBUR INSTRUMENTS. NO PROBLEM DETECTED ONCE ANOTHER BEAD LOT WAS USED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1430506 | BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES | COUNTER, DIFFERENTIAL CELL | GKZ | BECTON DICKINSON AND COMPANY BD BIOSCIENCES | 22103 | 00382906630285 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |