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 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that a cell-dyn emerald platelet result of approximately 18 k/ul was generated for a venous sample from a chemotherapy patient.Due to the low value, a second sample was drawn shortly after and the platelet result was approximately 60 k/ul.Both samples were mixed thoroughly and retested multiple times.All results from the first sample were between 12 and 18 k/ul while results from the second sample were approximately 60 k/ul.Blood smear estimate showed platelet count close to 20 k/ul.Both samples were sent to another facility and tested on a cell-dyn ruby analyzer.The platelet count for the first sample was 19 k/ul and for the second sample 25 k/ul.The result of 18 k/ul was reported to the physician as the customer determined it to be the correct result.No adverse impact to patient management was reported due to the falsely elevated result of 60 k/ul being generated.

Manufacturer Narrative

No patient samples were available from the customer for testing.Investigation consisted of review of product historical data and product labeling.Review of product historical data for any trends and all customer complaints received for this issue did not identify any adverse trends or abnormal complaint activity.A review of labeling concluded that the issue is sufficiently addressed.The issue was determined to be sample specific since the first sample and the second sample repeated consistently.Based on the available information, a product deficiency was not identified for the cell-dyn emerald, list number 09h39-01 for the complaint issue.

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred.

• 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: 6291163
• MDR Text Key: 66216209
• Report Number: 2919069-2017-00004
• 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: Medical Technologist
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• 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: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2013
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1