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

Model Number 09H39-01

Device Problem High Test Results (2457)

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

Event Date 01/11/2022

Event Type  malfunction  

Event Description

The customer observed falsely elevated hemoglobin results generated on the cell-dyn emerald instrument for one patient.The initial hemoglobin result was 9.2 g/dl, repeated at labcore 5.3 g/dl.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.

Manufacturer Narrative

The customer submitted data to aid this investigation.The investigation included a review of product historical data and product labeling.A review was performed for any trends and all customer complaints received for this issue.The review of this data did not identify any trends or abnormal complaint activity.Labeling was found to be adequate for the complaint issue.Review of the attached data found that the cd emerald flagged multiple parameters for all of the patients as being outside of the patient limits (shown with either an l or h), indicating that verification of results may be required per the laboratory¿s protocol.In particular, the hemoglobin (hgb) results for patients 1 and 2 were flagged with an h and patient 3 was flagged with an l.Multiple interpretive messages were generated by the cd emerald.The platelet and mpv results for patient 3 were flagged with an asterisk for count invalidation.Based on the information provided, the issue was resolved by field service replacing the counting chambers w/o aperture.Based on the complaint investigation, a deficiency was not identified.

• Brand Name: CELL-DYN EMERALD 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 N39 E-932 ; 433331157
• MDR Report Key: 13395656
• MDR Text Key: 286884707
• Report Number: 2919069-2022-00003
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081495
• 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: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1