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

Model 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	08/04/2021
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 questioned elevated cell-dyn emerald platelet (plt) results generated for a pediatric patient.Sample: platelet results of 590 and 751 k/ul.Sample: platelet results of 684 and 1178 k/ul.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
The investigation included a review of product historical data and product labeling.A review was performed for any trends and all customer complaints received for this issue.The review of this data did not identify any adverse trends or abnormal complaint activity.Labeling was found to be adequate for the complaint issue.Based on the information provided, the issue of elevated plt results was resolved with calibration performed by service.No product deficiency was identified.

• Brand Name: CELL-DYN EMERALD SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 12355107
• Report Number: 2919069-2021-00017
• Device Sequence Number: 14536360
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 09H39-01
• Device Catalogue Number: 09H39-01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1