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	05/10/2021
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.Section a patient information: no further patient information was provided.
Event or Problem Description
The customer obtained a falsely elevated platelet result while using the cell-dyn emerald analyzer.On (b)(6) 2021 the sample generated an initial high result of 1162 k/ul and repeat of 303 k/ul.No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information in section a2.Patient age was added.Investigation of the customer's issue included review of complaint text and information provided by the customer, as well as review of device history records and trending reports.Review of complaint activity and trending reports did not identify any trends associated with the complaint issue.Device history record associated with the analyzer did not identify any non-conformances associated with the complaint issue.Review of the complaint issue and information provided by the customer found the plt result was at panic high (h) to alert the customer.The specimen was capillary blood collected by prick (finger or heel).When comparing the initial results and the repeat results, beside a huge difference (383%) for plt, it also showed -10% difference for wbc (5.3 vs 4.8) and +8.7% difference for rbc (4.69 vs 5.10).This count-to-count variation indicated that inadequate sample mixing due to limited sample volume may have caused the issue reported in this ticket.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the cell-dyn emerald analyzer 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: 12033156
• Report Number: 2919069-2021-00014
• Device Sequence Number: 960885
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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: 06/01/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 YR