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 12/10/2015

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(4).

Event Description

On (b)(6) 2015 the customer reports that one patient sample generated an initial platelet count of 798 k/ul on a cell-dyn emerald analyzer.The sample retested at 1000 k/ul.The same patient generated a platelet result of 457 k/ul the previous year.Controls were within specifications and a precision run performed the previous day was within specifications.There is no impact to patient management reported.

Manufacturer Narrative

There were no returns from the customer site for this evaluation.In addition, no further patient information or current instrument status was provided by the customer.Abbott field service visited the customer site and replaced dirty/contaminated instrument components.Subsequent instrument operations were acceptable.A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.The cell-dyn emerald operator manual contains information to address the current customer issue.Based on the available information, the status of the instrument requiring service and maintenance could not be eliminated as possible cause for the customer's current issue.The event was instrument specific and a product issue was not identified.Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product deficiency is present.The issue was addressed through standard troubleshooting procedures.

• 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: 5333041
• MDR Text Key: 35068360
• Report Number: 2919069-2015-00092
• Device Sequence Number: 1
• Product Code: GKZ
• 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: 01/29/2016

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2014
• 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