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	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated platelet results generated on the cell-dyn emerald for one sample when compared to another method.The following data was provided: (b)(6) emerald result =142, repeat = 100, advia result = 3.No impact to patient management was reported.
Additional Manufacturer Narrative
(b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated platelet results generated on the cell-dyn emerald when compared to another method.The following data was provided: sid (b)(6): platelet: emerald =142, repeat = 100, advia = 3.No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) performed various maintenance activities and verified that the instrument passed precision twice using controls.However, precision failed on rbc and plt when using a fresh patient sample.The fse replaced the syringe body and seal plate and performed flushing and backwash.After the service, precision with the blood passed.Quality control (qc) was performed, and all results were within range.The cell dyn emerald analyzer was operating properly for a while, but the issue returned.The cell dyn emerald analyzer generated plt results that were different compared to the other instruments.The instrument maintenance record (event log) was not available for a review.Per customer¿s request, the instrument was removed from the site and no further investigation could be performed.A review of tracking and trending of the cell dyn emerald did not identify any trends associated with the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the cell dyn emerald for serial 5793 was identified.Section g1 has been updated to current contact information.

• 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
• 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 ; EI N39 E932 ; 2246682940
• MDR Report Key: 12856216
• Report Number: 2919069-2021-00024
• Device Sequence Number: 5082196
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2014
• 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