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

Model Number	09H39-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
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 stated that a patient sample was tested three times on the cell-dyn emerald analyzer and discrepant results were observed.Results were not reported to the physicians.Patient 1: 1st run, 2nd run, 3rd run (expected values) wbc: 11.1, 1.2, 8.5 (4 - 12 10^3/ul) rbc: 5.52, 1.69, 4.48 (4 - 6.20 10^6/ul) hgb: 13.8, 1.9, 11.0 (11 - 17 g/dl) mcv: 87.9, 88.2, 87.1 (80 - 100 fl) plt: 496, 365, 116 (150 - 400 10^3/ul) no impact to patient management was reported.
Event or Problem Description
The customer stated that a patient sample was tested three times on the cell-dyn emerald analyzer and discrepant results were observed.Results were not reported to the physicians.Patient 1: 1st run, 2nd run, 3rd run (expected values).Wbc: 11.1, 1.2, 8.5 (4 - 12 10^3/ul).Rbc: 5.52, 1.69, 4.48 (4 - 6.20 10^6/ul).Hgb: 13.8, 1.9, 11.0 (11 - 17 g/dl).Mcv: 87.9, 88.2, 87.1 (80 - 100 fl).Plt: 496, 365, 116 (150 - 400 10^3/ul).No impact to patient management was reported.
Additional Manufacturer Narrative
The customer issue was resolved with site visit troubleshooting.Specimen results, qc data, precision data, and calibration data were submitted for review.Review of the data found that lym, mid, and gra parameters were flagged as invalid and l5 (large size cells present) flag was generated.Instrument event log was not available for review.Instrument service was requested and performed on june 1, 2023.The system was cleaned and lubricated.Gain checking/adjustment, precision check, and calibration were performed.Quality control passed after the service.No issue was reported after the service.Trending review determined no trend for the issue for the product.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no 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
• 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: 17156307
• Report Number: 2919069-2023-00019
• Device Sequence Number: 11747675
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/19/2023

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: 09H39-01
• Device Catalogue Number: 09H39-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2020
• 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