MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN EMERALD; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number 09H39-01

Device Problem Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2015

Event Type  malfunction  

Event Description

The customer indicated that sample ids were mismatched while using the cell-dyn emerald analyzer.No specific data is available from the customer.No impact to patient management was reported.

Manufacturer Narrative

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

Manufacturer Narrative

Further evaluation of the customer issue included a review of the complaint text, a review of the instrument service history, a search for similar complaints, and a review of product labeling.The customer has indicated that there was no issue with the barcode reader.Review of the instrument service history did not identify any other issues that may have contributed to the current event.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the cell-dyn emerald analyzer, list number 09h39 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: 4906776
• MDR Text Key: 6837021
• Report Number: 2919069-2015-00039
• 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: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• 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: 07/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1