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

Catalog Number	08H67-03
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2024
Type of Reportable Event	Malfunction
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 observed a sampling aspiration error on the cell-dyn ruby analyzer.The field service representative (fsr) inspected the analyzer and found charred j17 and j18 connector cables and the respective connector pins for j17 and j18 also had charring.There was no impact to patient management reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the cell-dyn ruby analyzer serial number (b)(6) and found charred j17 and j 18 connector cables and pins on the ca assy, cdm 2 pwr, cdruby.The fsr cleaned the part, reseated the cables, and reinitialized the instrument which resolved the issue.Return testing was not completed as returns were not available.The instrument service history review revealed no additional tickets associated with smoke or charring.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of tracking and trending of the ca assy, cdm 2 pwr, cdruby did not identify any trends associated with the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint 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 serial number (b)(6) or the ca assy, cdm 2 pwr, cdruby was identified.
Event or Problem Description
The customer observed a sampling aspiration error on the cell-dyn ruby analyzer.The field service representative (fsr) inspected the analyzer and found charred j17 and j18 connector cables and the respective connector pins for j17 and j18 also had charring.There was no impact to patient management 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: 20906257
• Report Number: 2919069-2024-00070
• Device Sequence Number: 11764369
• Product Code: GKZ
• UDI-Device Identifier: 00380740099916
• UDI-Public: (01)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): 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): 01/17/2025

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: 08H67-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2006
• 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: CA ASSY, CDM 2 PWR, CDRUBY, 8952200901, UNKNOWN
• Patient Sex: Unknown