MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ECOTERGENT; GENERAL PURPOSE REAGENT

Model Number ECOTERGENT

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

The event occurred in (b)(6).

Event Description

The initial reporter alleged that while cleaning the sample line on the cobas 6000 e 601 module they got the detergent eco-d / ecotergent in the eye.The customer did not wear protective glasses.The customer stated that this occurred while they were injecting into the sample syringe tubing.When the wash solution contacted the customer's eye, the eye was immediately rinsed with saline the customer went to the hospital for consultation.The customer did not have eye lesions and was given antibiotic cream and eyedrops.Later in the day, the customer was better and her vision was not impaired.Product labeling for the eco-d / ecotergent states to wear protective gloves / protective clothing / eye protection/ face protection.Product labeling for the e601 states to wear appropriate protective equipment, including, but not limited to: safety glasses with side shields, fluid-resistant lab coat, and approved disposable gloves.

• Brand Name: ECOTERGENT
• Type of Device: GENERAL PURPOSE REAGENT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8914589
• MDR Text Key: 155098338
• Report Number: 1823260-2019-03055
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2019

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 Model Number: ECOTERGENT
• Device Catalogue Number: 07734522001
• Device Lot Number: ASKU
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/21/2019
• 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): Other