MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD¿ STEM CELL ENUMERATION; COUNTER, DIFFERENTIAL CELL

Catalog Number	344563
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: BD¿ STEM CELL ENUMERATION
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 155 north mccarthy boulevard; milpitas CA 95035
• Manufacturer (Section G): BD CARIBE, LTD; vicks drive; lot no. 1; cayey PR
• Manufacturer Contact: fahmy razak - mdr ; 155 north mccarthy boulevard; milpitas, CA 95035 ; 8772328995
• MDR Report Key: 22816971
• Report Number: 2647876-2025-00261
• Device Sequence Number: 5790901
• Product Code: OYE
• UDI-Device Identifier: 00382903445639
• UDI-Public: (01)00382903445639(11)241224(17)260531(10)4359181
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 344563
• Device Lot Number: 4359181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/24/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown