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 Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient information: no specific patient information was provided.

Event Description

The customer reported they obtained falsely elevated platelet results on the cell-dyn emerald analyzer for multiple patients.The customer indicated they obtained initial results between 1000 and 12000 and repeat of the samples generate normal results.The following results were provided as examples.Patient 2 generated results of 1387 and 283, patient 4 generated a result of 1085 and retest in normal range, patient 5 generated a result of 1333 and retest in normal range.No specific patient information was provided and no adverse impact to patient management was reported.

Manufacturer Narrative

The investigation included a review of submitted information and data, product historical data, labeling, and consultation with medical affairs.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.The associate medical director reviewed the available information and concluded an issue with the platelete aperture such as clog or contamination may have contributed to the issue.The field service representative resolved the issue by replacing the rbc counting head.Following replacement of the rbc counting head precision and controls were performed generating acceptable results.Additionally, labeling was reviewed and sufficiently addresses the customers issue.No systemic issue or deficiency of the cell-dyn emerald analyzer 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
• 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: 7280857
• MDR Text Key: 100653575
• Report Number: 2919069-2018-00013
• 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: 03/22/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/19/2018
• Supplement Dates Manufacturer Received: 03/12/2018
• Supplement Dates FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2013
• 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