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	03/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely depressed hemoglobin result generated on the cell dyn emerald for one sample on (b)(6) 2021.The following data was provided: hemoglobin results = 3.0 g/dl, repeats = 10.0 g/dl and 13.0 g/dl no impact to patient management was reported.
Additional Manufacturer Narrative
(b)(4).Was this device serviced by a third party? no.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The customer performed cleaning and flushing as troubleshooting instructed by the customer service over phone.Preventive maintenance (pm) was also arranged and completed and no instrument issue was found.Field service could not reproduce the complaint issue during the service visit.The results from the first count were overly low for all main parameters (wbc/rbc/hgb/plt), followed by gradually increased rbc and hgb in each subsequent run.This indicated a possibility of inadequate mixing probably due to limited sample volume in a capillary tube, which resulted in the initial depressed results as well as count-to-count variations observed in this ticket.A review of tracking and trending did not identify any trends for 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 investigation no systemic issue or deficiency of the cell-dyn emerald, serial number (b)(6) was identified.This follow up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.

• 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: 11685672
• Report Number: 2919069-2021-00012
• Device Sequence Number: 19604203
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/17/2021

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: 03/24/2021
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1