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

Catalog Number	09H39-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated platelet (plt) results generated on the cell-dyn emerald that do not match the patient¿s clinical history.The following data was provided (customer¿s reference range 140 ¿ 440 k/ul): sample id (b)(6) initial result = 76 k/ul, repeat result at another lab on another cell-dyn emerald = 20 k/ul, repeat result at another lab on beckman coulter = 9 k/ul it was noted that the customer believes that the results of 20 and 9 are correct as they match the patient¿s clinical history.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final 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 falsely elevated platelet (plt) results generated on the cell-dyn emerald that do not match the patient¿s clinical history.The following data was provided (customer¿s reference range 140 ¿ 440 k/ul): sample id (b)(6) initial result = 76 k/ul, repeat result at another lab on another cell-dyn emerald = 20 k/ul, repeat result at another lab on beckman coulter = 9 k/ul.It was noted that the customer believes that the results of 20 and 9 are correct as they match the patient¿s clinical history.No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information section h4 - device mfg date: updated from blank to 9/18/2023.The field service representative (fsr) inspected the instrument and decontaminated it which resolved the issue.Return testing was not completed as returns were not available.No additional discrepant result issues have been reported since the service activity was completed.A review of tracking and trending for the cell-dyn emerald did not identify an increase in complaint activity.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the cell-dyn emerald for serial (b)(6) was identified.

• 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: 21249039
• Report Number: 2919069-2025-00002
• Device Sequence Number: 9179602
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: (01)00380740020088
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/20/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2023
• 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