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 12/28/2016

Event Type  malfunction  

Manufacturer Narrative

Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is completed.

Event Description

The customer stated that the cell-dyn emerald analyzer generated a falsely elevated platelet (plt) result on one patient.The results provided were: initial greater than (b)(6) / repeat is normal.The sample was tested on another emerald analyzer and the result was also normal.There was no reported impact to patient management.There was no additional patient information provided.

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, trend reports, complaint searches, and product labeling.There was no patient sample provided to assist in the investigation.A review of product historical data for any trends and/or customer complaints received for this issue, did not identify any trends or abnormal complaint activity.A review of product labeling shows adequate information is provided to troubleshoot the falsely increased patient result.Based on the available information, a product deficiency was not determined for the cell-dyn emerald, list number 09h39-01 or for the counting chamber without aperture, list number 8701685903.

• 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
• Manufacturer (Section G): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6259720
• MDR Text Key: 65073003
• Report Number: 2919069-2017-00003
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1