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

Catalog Number	08H00-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed white blood cell (wbc) values generated on a cell-dyn sapphire.After an interval without measurements, wbc would be zero and platelets would also be slightly low, running a second time would produce results with no issues.No actual data had been provided at that time.The customer replaced the peristaltic pump but continued to see falsely depressed wbc and absolute neutrophils for one patient sample.On (b)(6) 2026, sid (b)(4) initial wbc result = 0.130 10e3/ul, repeat result = 9.08 10e3/ul; initial seg = 0.013 10e3/ul, repeat result = 7.19 10e3/ul.There was no impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.All available patient information was included.Additional patient details are not provided.
Additional Manufacturer Narrative
The field service representative inspected the cell-dyn sapphire, serial number 43027az, replaced and calibrated the valve pilot no (part number 8310844101) and perist pmp tbg-md (part number 91485-01), which were deemed the cause of the issue.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The instrument service history review revealed no additional complaints associated with the customer reported event.A review of tracking and trending did not identify any trends for the cell-dyn sapphire or valve pilot no and perist pmp tbg-md with regards to the customer reported event.A review of the manufacturing documentation did not identify any issues for the valve pilot no and perist pmp tbg-md as it relates to the customer reported event.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the cell-dyn sapphire serial number 43027az or the valve pilot no and perist pmp tbg-md.
Event or Problem Description
The customer observed falsely depressed white blood cell (wbc) values generated on a cell-dyn sapphire.After an interval without measurements, wbc would be zero and platelets would also be slightly low, running a second time would produce results with no issues.No actual data had been provided at that time.The customer replaced the peristaltic pump, but continued to see falsely depressed wbc and absolute neutrophils for one patient sample.On 13mar2026, sid 52600016939 initial wbc result = 0.130 10e3/ul, repeat result = 9.08 10e3/ul; initial seg = 0.013 10e3/ul, repeat result = 7.19 10e3/ul.There was no impact to patient management.

• Brand Name: CELL-DYN SAPPHIRE
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 647 almanor ave.; sunnyvale CA 94085
• Manufacturer (Section G): ABBOTT LABORATORIES; 647 almanor ave.; sunnyvale CA 94085
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 24746353
• Report Number: 2919069-2026-00005
• Device Sequence Number: 21123559
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2010
• 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 Age: 24 MO
• Patient Sex: Female