MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS, INC 10X EZ PREP SOLUTION, 2L; GENERAL PURPOSE REAGENT

Catalog Number 05279771001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Eye Injury (1845); Loss of Vision (2139); Reaction (2414); Chemical Exposure (2570)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

The warnings and precautions section of the ez prep concentrate (10x) instructions for use indicate to take reasonable precautions when handling reagents.Avoid contact of reagents with eyes, skin, and mucous membranes.Use protective clothing and gloves.Additionally, the safety data sheet for the solution indicates that the product can cause serious eye damage/irreversible tissue damage and blindness, and to wear protective gloves/ eye protection/ face protection.If the solution gets in eyes, there is indication to rinse immediately with plenty of water and seek medical advice.The date of the event is unknown, and indicated to have occurred in 2018.For this report, the date of event is captured as (b)(6) 2019, as this was the date the injury was reported to roche.(b)(4).

Event Description

A customer in portugal suspected that 10x ez prep solution, 2l, splashed in an operator's eye and caused irreversible eye damage.The operator was not wearing eye protective glasses/goggles, although advised in the product labeling, when disposing the waste.At the time of the suspected event, the operator did not feel any discomfort and did not seek immediate medical attention.The loss of vision was identified during a subsequent, routine eye exam performed months after the suspected event.The affected operator does not know if this loss of vision on the right eye started in 2018 or many years ago, since she did not go for yearly eye examinations.The 10x ez prep solution, 2l contains an aqueous-based detergent solution with 0.5% proclin 300 as a preservative.It is used for paraffin removal from tissue samples during immunohistochemistry and in situ hybridization reactions, and to dilute 2x ssc during stringency washes during in situ hybridization reactions carried out on ventana automated slide stainers.This product is designed for use on benchmark series automated slide stainers.

• Brand Name: 10X EZ PREP SOLUTION, 2L
• Type of Device: GENERAL PURPOSE REAGENT
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS, INC; 1910 e innovation park dr; tucson AZ 85755
• Manufacturer Contact: stacie-ann creighton ; 1910 e innovation park dr; na; tuscon, AZ 85755 ; 9082537112
• MDR Report Key: 8692915
• MDR Text Key: 147859969
• Report Number: 2028492-2019-00010
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 05279771001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Disability
• Patient Age: 42 YR