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

Catalog Number 09H39-01

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account generated false elevated platelet of 1302 k/ul on a patient sample that repeated 430, 341, 297 k/ul when processing on the cell-dyn emerald.No impact to patient management was reported.No specific patient information was provided.

Manufacturer Narrative

Abbott field service representative (fsr) visited the site and noticed the instrument tubing looking very discolored.Further investigation found the syringe body and seal plate cracked.Fsr replaced tubing, syringe and seat plate, ran start up, precision and control, all recovered within specification.A service request record search for cd emerald analyzer, (b)(4), was performed.In addition, historical data and tracking and trending searches were performed.No adverse trends or product issues were found.A review of the product labeling concluded that the issue is sufficiently addressed.No product deficiency was identified.

• Brand Name: CELL-DYN EMERALD
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 7907354
• MDR Text Key: 122470717
• Report Number: 2919069-2018-00047
• 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: 11/03/2018

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 Catalogue Number: 09H39-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/29/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 10/08/2018
• Supplement Dates FDA Received: 11/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1