BD¿ STEM CELL ENUMERATION
Report
- Report Number
- 2647876-2025-00261
- Event Type
- Malfunction
- Date Received
- August 15, 2025
- Date of Event
- July 18, 2025
- Report Date
- October 24, 2025
- Manufacturer
- BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
- Product Code
- OYE
- UDI-DI
- 00382903445639
- PMA / PMN Number
- SEE H.11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF LOT-TO-LOT VARIABILITY IN CD45+ VALUES RESULTS OBTAINED AGAINST PRODUCT 344563 (STEM CELL ENUMERATION KIT, IVD) LOT 4359181 WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: ¿ INFORMATION PROVIDED BY CUSTOMER EVALUATED. ¿ RETENTION SAMPLES WERE TESTED FOR STEM CELL REAGENT STAINING PERFORMANCE TO DETECT CD45 AND CD34 MARKERS, AND ABSOLUTE COUNT TUBES BEAD COUNT RESULTED IN ACCEPTABLE PERFORMANCE AND BEAD COUNT CONTENT. ¿ BATCH HISTORY RECORD (BHR) WAS EVALUATED AND FOUND IN COMPLIANCE WITH BD RELEASE SPECIFICATIONS. ¿ POTENTIAL CAUSE WAS NOT DETERMINED. NO PERFORMANCE ISSUE WAS IDENTIFIED. THE ISSUE WAS RESOLVED AFTER PROVIDING CUSTOMER WITH A REPLACEMENT KIT. 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.
D.1. ADDITIONAL MEDICAL DEVICE TYPE: GKZ. E.1. INITIAL REPORTER ADDITIONAL E-MAIL: (B)(6). E.1. INITIAL REPORTER ADDRESS: (B)(6). G.1. PMA / 510(K)#: BK110037;BK210652. 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 AFTER USE OF BD¿ STEM CELL ENUMERATION ERRONEOUS RESULTS WERE ACQUIRED AND PROVIDED TO CLINICIAN. THERE WAS NO IMPACT TO PATIENT AS THE CELL TRANSPLANTATION WAS STILL SUFFICIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER A DETAILED ANALYSIS, IT WAS IDENTIFIED THAT, WHEN COMPARING THE SAME SAMPLES ANALYZED WITH THE NEW KIT (RECENTLY PUT INTO USE) AND WITH THE OLD KIT, THERE WAS A DIFFERENCE OF 30% TO 40% IN CD45+ VALUES. THEREFORE, WE BELIEVE THAT THERE MAY BE A PROBLEM WITH THIS NEW KIT, WHICH AFFECTED THE ACCURACY OF THE TESTS PERFORMED.
IT WAS REPORTED THAT AFTER USE OF BD¿ STEM CELL ENUMERATION ERRONEOUS RESULTS WERE ACQUIRED AND PROVIDED TO CLINICIAN. THERE WAS NO IMPACT TO PATIENT AS THE CELL TRANSPLANTATION WAS STILL SUFFICIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER A DETAILED ANALYSIS, IT WAS IDENTIFIED THAT, WHEN COMPARING THE SAME SAMPLES ANALYZED WITH THE NEW KIT (RECENTLY PUT INTO USE) AND WITH THE OLD KIT, THERE WAS A DIFFERENCE OF 30% TO 40% IN CD45+ VALUES. THEREFORE, WE BELIEVE THAT THERE MAY BE A PROBLEM WITH THIS NEW KIT, WHICH AFFECTED THE ACCURACY OF THE TESTS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2788379 | BD¿ STEM CELL ENUMERATION | COUNTER, DIFFERENTIAL CELL | OYE | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES | 4359181 | 00382903445639 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |