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

Model Number 09H5901

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  malfunction  

Event Description

The customer observed a falsely elevated hemoglobin result generated on the cell-dyn emerald when compared to another method.The following data was provided: initial result = 8.8 g/dl, the patient had a new sample drawn at another laboratory using siemens sysmex = 7.1.The samples were collected on the same day and the patient did not receive treatment in between the blood draws.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a falsely elevated hemoglobin result generated on the cell-dyn emerald when compared to another method.The following data was provided: initial result = 8.8, the patient had a new sample drawn at another laboratory using siemens sysmex = 7.1 the samples were collected on the same day and the patient did not receive treatment in between the blood draws.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely elevated hemoglobin results generated on the cell-dyn emerald included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances with the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the cell-dyn emerald for serial (b)(6) was identified.Section g1 has been updated to current contact information.

• Brand Name: CELL-DYN EMERALD 22 SYSTEM
• Type of Device: 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, IL N39 E-932 ; 2246682940
• MDR Report Key: 13005658
• MDR Text Key: 288899901
• Report Number: 2919069-2021-00025
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740020286
• UDI-Public: 00380740020286
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

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
• Device Operator: Health Professional
• Device Model Number: 09H5901
• Device Catalogue Number: 09H59-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 02/11/2022
• Supplement Dates FDA Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1