MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN EMERALD 22 AL, INSTRUMENT; COUNTER, DIFFERENTIAL CELL

Model Number	04R1301
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely elevated platelet result for one patient sample when running on the cell dyn emerald.The following data was provided: 1 example of platelet results (unit of measurement: k/¿l): (b)(6) 2023: 1st measurement 1054 / 2nd measurement 234 there was no impact to patient management reported.
Event or Problem Description
The customer reported a falsely elevated platelet result for one patient sample when running on the cell dyn emerald.The following data was provided: 1 example of platelet results (unit of measurement: k/¿l): 04may2023: 1st measurement 1054 / 2nd measurement 234 there was no impact to patient management reported.
Additional Manufacturer Narrative
Specimen reports were provided by the customer.Review of the specimen reports confirmed platelet flagging with s and h but no (*).During the service of the cell dyn emerald 22 al instrument, serial number (b)(6), a brown crystal deposit was found in the wbc chamber.This could be indicative of maintenance or waste management issues.Field service lubricated the syringe plungers, changed the position of the hose for liquid waste and cleaned the counting chambers.The waste line was fed directly into a waste container to prevent liquid backup.After the waste management change and maintenance was performed, no additional issues pertaining to platelet imprecision have been reported.A review of all complaints associated and a review of complaint trends for the list number 04r13-01 was performed.The review did not identify any related trends and no increase in complaint activity.A review of the device history record did not identify an issue with the product.Labeling was reviewed and adequately addressed the issue under review.Based on the investigation, no systemic issue or product deficiency was identified with cell dyn emerald 22 al instrument, serial number (b)(6).

• Brand Name: CELL-DYN EMERALD 22 AL, 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17059372
• Report Number: 2919069-2023-00016
• Device Sequence Number: 5164038
• Product Code: GKZ
• UDI-Device Identifier: 00380740136093
• UDI-Public: 00380740136093
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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: 04R1301
• Device Catalogue Number: 04R13-01
• 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: 07/19/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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