BD MULTITEST¿
Report
- Report Number
- 3008352382-2024-00002
- Event Type
- Malfunction
- Date Received
- March 15, 2024
- Date of Event
- February 19, 2024
- Report Date
- August 29, 2024
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- GKZ
- UDI-DI
- 00382906629678
- PMA / PMN Number
- SEE H.10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H.6 IMDRF ANNEX B: B21. H.6 IMDRF ANNEX C: C21. H.6 IMDRF ANNEX D: D16.
D.4. MEDICAL DEVICE EXPIRATION DATE: NA. E.1. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. G.5. PMA / 510(K)#: K090967. G.5. PMA / 510(K)#: K170974. H.3. A DEVICE EVALUATION AND OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6: BASED ON THE INVESTIGATION RESULTS, THE REPORTED PERFORMANCE ISSUE DEFECT OF BACKGROUND SIGNAL AGAINST PRODUCT 662967 (BD MULTITEST 6-COLOR TBNK REAGENT, IVD) LOT 34028 WAS CONFIRMED BUT REPORTED DEFECT WAS NOT REPRODUCED AND THIS PRODUCT LOT PERFORMED AS INTENDED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: RETAIN SAMPLE TESTING BY FLOW CYTOMETRY, SUBASSEMBLY MATERIAL BHR REVIEW INCLUDING FLOW CYTOMETRY DATA OBTAINED DURING RELEASE TESTING AGAINST REFERENCE BATCH. BASED ON INVESTIGATION RESULTS, A POTENTIAL CAUSE WAS NOT DETERMINED. 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.
IT WAS REPORTED THAT WHILE USING BD MULTITEST¿ ERRONEOUS RESULTS WERE OBSERVED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND THAT AS LONG AS THIS LOT(34028) IS STAINED, IN THE CD45 VS SSC , ,CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT ANY NOISE. VERY CLEAN CD45 STAIN UNLIKE LOT 34028. THIS WILL CAUSE INCORRECT RESULT FOR BOTH CD4+ AND CD8+% AND CELL COUNTS.
IT WAS REPORTED THAT WHILE USING BD MULTITEST¿ ERRONEOUS RESULTS WERE OBSERVED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND THAT AS LONG AS THIS LOT (34028) IS STAINED, IN THE CD45 VS SSC , CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT ANY NOISE. VERY CLEAN CD45 STAIN UNLIKE LOT: 34028. THIS WILL CAUSE INCORRECT RESULT FOR BOTH CD4+ AND CD8+% AND CELL COUNTS.
IT WAS REPORTED THAT WHILE USING BD MULTITEST¿ ERRONEOUS RESULTS WERE OBSERVED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND THAT AS LONG AS THIS LOT(34028) IS STAINED, IN THE CD45 VS SSC , ,CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT ANY NOISE. VERY CLEAN CD45 STAIN UNLIKE LOT 34028. THIS WILL CAUSE INCORRECT RESULT FOR BOTH CD4+ AND CD8+% AND CELL COUNTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1131761 | BD MULTITEST¿ | COUNTER, DIFFERENTIAL CELL | GKZ | BECTON DICKINSON CARIBE LTD. | 34028 | 00382906629678 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |