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

Catalog Number	08H67-01
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer heard an explosion/loud bang, smelled a burning odor, and observed smoke coming out of the cell-dyn ruby analyzer.The instrument shut down and the customer immediately disconnected the instrument.There was no visible evidence showing signs of fire on the outside of the cell-dyn ruby analyzer.Additionally, the customer reported there was no harm whatsoever to the users or the facilities in the laboratory.Further information was provided that during the visual inspection; there was evidence indicating that the cause was the lambda power supply which was then replaced.It was confirmed that the instrument no longer overheated or shut down.Backgrounds were processed within specifications and controls were processed within range.The instrument was delivered in good working order and was approved for routine use.No impact to patient management or impact to user safety was reported.
Additional Manufacturer Narrative
The field service representative was dispatched and replaced the power supply, spec, lambda, custom, cdruby of the cell-dyn ruby analyzer.The instrument service history for the cell-dyn ruby, serial number (b)(6) verifies no subsequent complaints have been reported related to smoke form a part.Data and information provided by the customer were reviewed and support the complaint issue.A review of complaint and trending data for cell-dyn ruby analyzer did not identify any similar issues related to the current issue.Additionally, review of complaint and trending data associated with power supply, spec, lambda, custom, cdruby did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any non-conformances and potential non-conformances related to the current issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the cell-dyn ruby analyzer for serial number (b)(6) or power supply, spec, lambda, custom, cdruby was identified.

• 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: 24698343
• Report Number: 2919069-2026-00004
• Device Sequence Number: 13299833
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: 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: 03/17/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: POWER SUPPLY, SPEC, LAMBDA, CUSTOM, CDRUBY, 893410
• Patient Sex: Unknown