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

Catalog Number 09H39-01

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A product recall letter has been issued to all customers who have installed instruments with the impacted serial numbers and customers who have received the impacted emerald diluent tubing.The letter informs the customer of the following: - abbott representative will be contacting them to schedule an appointment to replace the tubing.The customer may continue to operate their instrument per the requirements outlined in section 5 of the operators manual, background counts must be within acceptable limits before running controls or patient specimens and all data should be considered for patient care management.If the results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.

Event Description

The customer was notified of the product recall for the cell-dyn emerald diluent tubing on the cell-dyn emerald analyzer and subsequently requested replacement of the tubing.No impact to patient management was reported.

• Brand Name: CELL-DYN EMERALD ANALYZER
• 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: 8704715
• MDR Text Key: 149089929
• Report Number: 2919069-2019-00069
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• 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: 05/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 2919069-05/09/19-002-R
• Patient Sequence Number: 1