MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN SAPPHIRE SYSTEM; COUNTER, DIFFERENTIAL CELL

Catalog Number	08H00-01
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	10/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed discrepant white blood count (wbc) and neutrophil absolute count generated from cell dyn sapphire analyzer for one patient.The results provided were: neutrophil absolute initial=1.00 10e3/l /repeated=0.1 10e3/l additional information provided: wbc=5.82 10e3/l /repeated=5.21 10e3/l there was no reported impact to patient management.
Additional Manufacturer Narrative
A review of product historical data for any trends and all customer complaints received for this issue did not identify any trends or increase in complaint activity.Return testing was not completed as returns were not available.A review of all complaints associated and a review of complaint trends was performed.The review did not identify any adverse trends.Additionally, labeling was reviewed and adequately addressed the issue under review.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the available information no product deficiency of the cell-dyn sapphire analyzer, serial number (b)(6), was identified.
Event or Problem Description
The customer observed discrepant white blood count (wbc) and neutrophil absolute count generated from cell dyn sapphire analyzer for one patient.The results provided were: neutrophil absolute initial=1.00 10e3/l /repeated= 0.1 10e3/l.Additional information provided: wbc =5.82 10e3/l /repeated= 5.21 10e3/l there was no reported impact to patient management.

• Brand Name: CELL-DYN SAPPHIRE SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 20706176
• Report Number: 2919069-2024-00065
• Device Sequence Number: 12787550
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: (01)00380740016616
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: Health Professional
• Device Catalogue Number: 08H00-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2006
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown