BD CD45(2D1) APC-H7
Report
- Report Number
- 2916837-2023-00167
- Event Type
- Malfunction
- Date Received
- August 14, 2023
- Date of Event
- May 30, 2023
- Report Date
- January 23, 2024
- Manufacturer
- BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
- Product Code
- OYE
- PMA / PMN Number
- K141468
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 ISSUE OF DIFFERENCES IN CD45 BRIGHTNESS, LOT 2363930 RESULTED IN LOWER MFI COMPARED TO LOTS 2311097 AND 3060161 WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: ¿ DHR OR BHR REVIEW FOR MANUFACTURE BATCH RECORD AND QC TESTING RELEASE. 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. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD CD45(2D1) APC-H7. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS ANTIBODY IS USED AS PART OF 2 ANTIBODY PRE-MIX FOR IMMUNOPHENOTYPING STAINING. AFTER PERFORMING PRE-MIX CHECKS OVER THE PAST MONTH, WE HAVE OBSERVED DIFFERENCES IN CD45 BRIGHTNESS, SPECIFICALLY THE USE OF LOT 2363930 WOULD RESULT IN LOWER MFI COMPARED TO LOTS 2311097 AND 3060161. SAMPLE AVAILABILITY (YES/NO INCLUDING PICK UP DETAIL INFORMATION): 2 BOTTLES LEFT. WAS THERE ANY ALLEGED INJURY OR HARM TO USER OR PATIENT? (GIVE DETAILED INFORMATION): NO. 1. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? 2. DID CARRYOVER HAPPEN ON PATIENT SAMPLES? 1. YES. 2. YES. WE ADDED THIS LOT IN MULTIPLE PREMIXES (PREPARED BY US) AND THEN USED IT FOR TESTING PATIENTS' SAMPLES. HOWEVER, AT THE MOMENT OF ANALYSIS, WE ADJUSTED OUR GATING STRATEGY TO AVOID THE LOW MFI AFFECTING RESULTS. SO EVEN IF THE DIFFERENT CD45 EXPRESSION HAS BEEN DETECTED IN PATIENTS SAMPLES, GATES HAVE BEEN MOVED TO AID THE CORRECT INTERPRETATION OF THE DATA.
IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD CD45(2D1) APC-H7. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS ANTIBODY IS USED AS PART OF 2 ANTIBODY PRE-MIX FOR IMMUNOPHENOTYPING STAINING. AFTER PERFORMING PRE-MIX CHECKS OVER THE PAST MONTH, WE HAVE OBSERVED DIFFERENCES IN CD45 BRIGHTNESS, SPECIFICALLY THE USE OF LOT 2363930 WOULD RESULT IN LOWER MFI COMPARED TO LOTS 2311097 AND 3060161. ¿ SAMPLE AVAILABILITY (YES/NO INCLUDING PICK UP DETAIL INFORMATION): 2 BOTTLES LEFT. ¿ WAS THERE ANY ALLEGED INJURY OR HARM TO USER OR PATIENT? (GIVE DETAILED INFORMATION): NO 1. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? 2. DID CARRYOVER HAPPEN ON PATIENT SAMPLES? 1. YES* 2. YES* *WE ADDED THIS LOT IN MULTIPLE PREMIXES (PREPARED BY US) AND THEN USED IT FOR TESTING PATIENTS' SAMPLES. HOWEVER, AT THE MOMENT OF ANALYSIS, WE ADJUSTED OUR GATING STRATEGY TO AVOID THE LOW MFI AFFECTING RESULTS. SO EVEN IF THE DIFFERENT CD45 EXPRESSION HAS BEEN DETECTED IN PATIENTS SAMPLES, GATES HAVE BEEN MOVED TO AID THE CORRECT INTERPRETATION OF THE DATA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307337 | BD CD45(2D1) APC-H7 | FLOW CYYTOMETRIC REAGENTS AND ACCESSORIES | OYE | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES | 2363930 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |