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U.S. Department of Health and Human Services

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

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ABBOTT DIAGNOSTICS DIVISION CELL-DYN EMERALD; AUTOMATED HEMATOLOGY ANALYZER Back to Search Results
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.
 
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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 Key7127792
MDR Text Key96032517
Report Number2919069-2017-00167
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00380740020088
UDI-Public00380740020088
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
K081495
Number of Events Reported1
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 Number09H39-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/05/2017
Initial Date FDA Received12/18/2017
Supplement Dates Manufacturer Received03/01/2018
Supplement Dates FDA Received03/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age37 YR
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