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

Catalog Number	09H39-01
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
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.
Event or Problem Description
During installation of the cell-dyn emerald the abbott field service engineer(fse) connected the printer, ups and barcode reader.When they then powered on the analyzer they observed a large spark.The ups, cell-dyn emerald and printer were non-functional after this occurred.No impact to patient management or user safety was reported.
Additional Manufacturer Narrative
The abbott field service representative (fsr) observed a large spark generated from the cell-dyn emerald serial number: (b)(6) when the printer, barcode reader and ups were connected, and the instrument was powered on.The ups was found to have wires that should have been fused together that were not.The instrument was not functional after the spark.The fsr determined the cell-dyn emerald, serial number: (b)(6), was the cause of the issue and cell-dyn emerald, serial number: (b)(6), was successfully installed to resolve the issue.The instrument service history review revealed no additional tickets associated with spark/smoke.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 did not identify any trends with regards to the current issue.The current ticket is the sole complaint related to spark/smoke for the cell-dyn emerald (09h39-01).The device history record was reviewed, and no non-conformance's or potential non-conformance's was identified.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the cell-dyn emerald, serial number: (b)(6), was identified.
Event or Problem Description
During installation of the cell-dyn emerald the abbott field service engineer (fse) connected the printer, ups and barcode reader.When they then powered on the analyzer they observed a large spark.The ups, cell-dyn emerald and printer were non-functional after this occurred.No impact to patient management or user safety was reported.

• Brand Name: CELL-DYN EMERALD INSTRUMENT
• 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: 23464581
• Report Number: 2919069-2025-00045
• Device Sequence Number: 13018793
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: (01)00380740020088
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K081495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: 09H39-01
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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