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

Model Number	08H67-03
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service representative (fsr) found a strong burning smell coming from the power supply lambda (power supply, spec, lambda, custom, cdruby).The power supply lambda was replaced which resolved the issue.Photos were provided to the manufacturer, therefore, return of the part was not needed.Review of tickets did not find any additional tickets related to the current issue.Trending review did not identify any trends.A review of product historical data did not find a product issue related to the complaint incident.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency was identified for the cell-dyn ruby, sn (b)(4).
Event or Problem Description
The customer observed visible smoke from the cell-dyn ruby analyzer but cannot determine where or which parts it¿s coming from.No impact to patient management was reported.No injury to the user was reported.

• Brand Name: CELL-DYN RUBY 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16526628
• Report Number: 2919069-2023-00007
• Device Sequence Number: 2644836
• Product Code: GKZ
• UDI-Device Identifier: 00380740099916
• UDI-Public: 00380740099916
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 03/10/2023

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 Model Number: 08H67-03
• Device Catalogue Number: 08H67-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2006
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: POWER SUPPLY, SPEC, LAMBDA, CUSTOM, CDRUBY, 893410.
• Patient Sex: Unknown