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

Model Number 09H39-01

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false decreased results for various hematology parameters when processing on the cell-dyn emerald.The following data was provided: 1st patient results from: (b)(6) 2019 and reference range: rbc: 2.16; 4.10-5.60.Hgb: 6.5; 11.5-17.0.Hct: 19.9; 34-50.0.Mcv: 92.3; 80-97.No flagging on wbc.(b)(6) 2019 and reference range: rbc: 2.16/2.4; 4.10-5.60.Hgb: 6.4/5.4; 11.5-17.0.Hct: 19.9/19.7; 34-50.0.Mcv: 91.7/92; 80-97.Wbc parameters have flaggings (*).(b)(6) 2019 and reference range: rbc: 3.45; 4.10-5.60.Hgb: 10.2; 11.5-17.0.Hct: 32.2; 34-50.0.Mcv: 93.4; 80-97.No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, troubleshooting by field service engineer (fse), a review of product historical data, and a review of product labeling.The field service engineer found inconsistent rinse of sample probe through rinse head due to cable tie around tubing number 10 and 21 being tight.Cable tie was replaced, after which system operation appeared normal.A review of the product historical data did not identify any trends for this issue.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• Brand Name: CELL-DYN EMERALD ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 9369364
• MDR Text Key: 184179349
• Report Number: 2919069-2019-00111
• 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
• Report Date: 01/27/2020

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
• Device Operator: Health Professional
• Device Model Number: 09H39-01
• Device Catalogue Number: 09H39-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1