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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer observed a falsely elevated platelet result on the cell-dyn emerald analyzer.The following data was provided: initial 1,000,000 k/ul, repeated too high to report, repeated again 415, 300 k/ul.There was no impact to patient management reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and instrument service.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The issue was resolved by replacing the o-rings kit and 1l straw.Based on all available information and abbott diagnostics' complaint investigation 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: 8124442
• MDR Text Key: 129444984
• Report Number: 2919069-2018-00059
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

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: 11/09/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 12/30/2018
• Supplement Dates FDA Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1