MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN EMERALD ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Model Number	09H39-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A product recall letter has been issued to all customers who have installed instruments with the impacted serial numbers and customers who have received the impacted emerald diluent tubing.The letter informs the customer of the following: abbott representative will be contacting them to schedule an appointment to replace the tubing.The customer may continue to operate their instrument per the requirements outlined in section 5 of the operators manual, background counts must be within acceptable limits before running controls or patient specimens and all data should be considered for patient care management.If the results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
Event or Problem Description
The customer reported the background count was too high for plt while using the cell-dyn emerald analyzer.The field service engineer was unable to complete service due to the covid 19 travel restrictions and it could not be confirmed if this customer was using impacted cell-dyn emerald diluent tubing.There was no patient involved and no reported impact to patient management.

• Brand Name: CELL-DYN EMERALD ANALYZER
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 10080411
• Report Number: 2919069-2020-00021
• Device Sequence Number: 3867073
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K081495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/21/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2919069-05/09/19-002-R
• Patient Sequence Number: 1