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

Model Number 09H39-01

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

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.

Event Description

The customer observed discrepant cbc (complete blood count) results for multiple patients and controls out of range on cell-dyn emerald.The one example patient results provided: on (b)(6) 2021, sid: (b)(6) hemoglobin=25.0 g/dl / repeated at another hospital=20.0 g/dl there was no reported impact to patient management.

Manufacturer Narrative

Component code: g03001.Abbott field service (fs) was requested for some maintenance after the issue.There were no additional discrepant results reported on the cell-dyn emerald, serial number (b)(6), after the service.A patient sample was not repeated on cell-dyn emerald and was sent to another lab and tested 3 hours later on an unknown analyzer.This unknown instrument was a 5-part differential analyzer which was different from the 3-part differential instrument like cell-dyn emerald.Results generated by the unknown analyzer were lower for wbc, rbc, hgb, mcv and hct, and higher for plt.Wbc differential also did not match the cell-dyn emerald results, but due to the different technologies, a direct comparison between cell-dyn emerald and this analyzer could not be made.The manual reading on wbc differential was also not exactly matched to either cell-dyn emerald or this unknown analyzer.Overall, the actual patient results could not be confirmed from the data provided in this ticket.The blood collection tube type was unknown, but it was likely a capillary sample.If the sample volume was very small, and/or if sample mixing was harder due to low sample volume, then count-to-count variation might potentially occur.Cell-dyn emerald only allowed open mode testing, and it was unknown which mode (open or closed if it could be chosen) was used on the other analyzer.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the cell-dyn emerald analyzer serial number (b)(6) was identified.

Manufacturer Narrative

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
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 11447083
• MDR Text Key: 240405405
• Report Number: 2919069-2021-00008
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (y/n): N
• PMA/PMN Number: K081495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2021

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
• Device Operator: Health Professional
• Device Model Number: 09H39-01
• Device Catalogue Number: 09H39-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 04/07/2021; 06/21/2021
• Supplement Dates FDA Received: 04/08/2021; 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1