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

Catalog Number	08H00-01
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that patient sample results are intermittently being recognized as control h when generated on the cell dyn sapphire.The customer would scan the barcode of the patient sample, and the barcode number displayed on the screen of the instrument is correct, however the sample is recognized as control h.The customer would repeat testing on the same sample, and the sample is recognized as a patient sample and not a control.There were no discrepant results reported.There was no issue with qc and no flags or error messages generated.The field service engineer (fse) arrived onsite to inspect the cell dyn sapphire and found that the default setting for the host measurement request was ¿qc¿.Therefore, when there is a communication issue such as a query timeout, the instrument automatically recognizes the sample as a qc sample.The default setting was changed for the measurement request to ¿patient sample¿.There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer stated that patient sample results are intermittently being recognized as control h when generated on the cell dyn sapphire.The customer would scan the barcode of the patient sample, and the barcode number displayed on the screen of the instrument is correct, however the sample is recognized as control h.The customer would repeat testing on the same sample, and the sample is recognized as a patient sample and not a control.There were no discrepant results reported.There was no issue with qc and no flags or error messages generated.The field service engineer (fse) arrived onsite to inspect the cell dyn sapphire and found that the default setting for the host measurement request was ¿qc¿.Therefore, when there is a communication issue such as a query timeout, the instrument automatically recognizes the sample as a qc sample.The default setting was changed for the measurement request to ¿patient sample¿.There was no impact to patient management reported.
Additional Manufacturer Narrative
The cell-dyn sapphire (list number 08h00-01), serial # (b)(6) was the subject of this investigation.A review of tracking and trending did not identify any similar issues or trends related to the current issue.A review of the device history record was reviewed and did not identify any non-conformance or deviations related to the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Service discovered the default setting for host measurement requests the issue occurred after the customer failed to correct default setting for host measurement requests from "qc" to ¿patient sample¿.Based on the investigation, the device met performance specifications and performed as intended at the customer site, therefore, no systemic issue or deficiency was identified.

• Brand Name: CELL-DYN SAPPHIRE
• 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: 23611690
• Report Number: 2919069-2025-00047
• Device Sequence Number: 9203455
• 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): 12/23/2025

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): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2016
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown