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

Catalog Number 09H39-01

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(4).He cleaned/flushed his face, no medical treatment was provided.

Event Description

The instrument technician ((b)(6) year old male) reported, after a repair of the cell-dyn emerald analyzer he proceeded to test the instrument without processing actual specimens with the right side cover open.While checking for liquid leaks and fluid levels during this testing the tubing of the diluent line came off and a small amount splashed his face.The technician was wearing goggles to protect his eyes, but the diluent splashed his face.The technician cleaned/flushed his face, no medical treatment was provided.

Manufacturer Narrative

The investigation included review of product historical data, product labeling, and consultation with medical affairs and on-market engineering.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.Tube 9, which popped off is connected to the sample probe and the sample syringe.Possible causes for tube 9 popping off may have been due to an obstruction inside the line or tube 9 was loosely or incorrectly connected.The customer stated the analyzer was decontaminated with diluted bleach and prepare for shipping instructions were ran per the cell-dyn emerald operations manual before the splash occurred.The technician further stated he was only running diluent into the system and there was no blood or control testing involved when the incident occurred.Based on the available information, the potential for biohazard can be excluded.The diluent reagent is chemically not a hazard.The technician was wearing protective glasses which protected his eyes from getting splashed, but a small amount of liquid splashed on his face.The technician performed the correct basic first aid action by immediately washing his face with water and no medical treatment was recommended.The material safety data sheet (msds) for list number 09h48-02 was reviewed and found the cell-dyn emerald diluent is a nonirritant and there is no dangerous decomposition products known.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: 7127792
• MDR Text Key: 96032517
• Report Number: 2919069-2017-00167
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K081495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

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: 12/05/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 03/01/2018
• Supplement Dates FDA Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2010
• 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
• Patient Age: 37 YR