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

Catalog Number	08H67-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 patient identifier: complete list of sample id's are (b)(6).The cell dyn ruby analyzer serial number (b)(6) was evaluated and it was determined that multiple parts required cleaning.The analyzer function was verified with a precision run.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 an increase in complaint activity for the cell dyn ruby analyzer with regards to the customer reported event.A review of the manufacturing documentation did not identify any issues for the cell dyn ruby analyzer 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 ruby analyzer serial number (b)(6).
Event or Problem Description
The customer observed falsely elevated platelet results generated on the cell dyn ruby analyzer after it enters a prolonged idle state.The following data was provided (reference values plt 150-450 10e3/ul; rbc 4.2-5.4 10e6/ul; wbc 5-10 10e3/ul): patient 1 sid (b)(6) 03/09/2025 7:04.Wbc 6.24 10e3/ul.Rbc 1.88 10e6/ul.Plt 989 10e3/ul.Sid no id (it is the same sample) 03/09/205 7:30.Wbc 5.88 10e3/ul.Rbc 2.33 10e6/ul.Plt 570 10e3/ul.Sid (b)(6) 03/09/2025 7:44.Wbc 9.65 10e3/ul.Rbc 3.40 10e6/ul.Plt 323 10e3/ul.Patient 2 sid (b)(6) 03/09/2025 3:37.Wbc 5.25 10e3/ul.Rbc 2.12 10e6/ul.Plt 984 10e3/ul.Sid no id (it is the same sample) 03/09/205 3:40.Wbc 5.17 10e3/ul.Rbc 3.08 10e6/ul.Plt 277 10e3/ul.Sid (b)(6) 03/09/2025 3:42.Wbc 5.56 10e3/ul rbc 3.20 10e6/ul.Plt 285 10e3/ul.Patient 3 sid (b)(6) 02/09/2025 6:50.Plt 1055 10e3/ul rbc 1.56 10e6/ul wbc 5.88 10e3/ul sid (b)(6) 02/09/2025 7:01.Plt 341 10e3/ul rbc 2.57 10e6/ul wbc 6.27 10e3/ul sid (b)(6) 02/09/2025 7:08.Plt 336 10e3/ul rbc 2.57 10e6/ul wbc 6.15 10e3/ul sid (b)(6) 02/09/2025 7:11.Plt 1016 10e3/ul rbc 1.67 10e6/ul wbc 6.42 10e3/ul sid (b)(6) 02/09/2025 7:14.Plt 663 10e3/ul rbc 2.06 10e6/ul wbc 6.03 10e3/ul sid (b)(6) 02/09/2025 7:28.Plt 385 10e3/ul rbc 3.33 10e6/ul wbc 9.53 10e3/ul.No impact to patient management was reported.

• Brand Name: CELL-DYN RUBY
• 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: 23067259
• Report Number: 2919069-2025-00041
• Device Sequence Number: 18608539
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)00380740017170
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K061667
• 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
• Report Date (Section B): 09/16/2025

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: 08H67-01
• 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: 09/03/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2016
• 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