MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS SYSCLEAN; GENERAL PURPOSE REAGENT

Model Number SYSCLEAN

Device Problem Leak/Splash (1354)

Patient Problem Irritation (1941)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter alleged that when changing reagents on a cobas e 411 immunoassay analyzer a drop of the ise cleaning solution / elecsys sysclean fell on her eye causing irritation.The user was taken to the emergency room for review, where they determined that the cleaning solution did not cause any damage to her eye.The user was medicated with paracetamol and tobramycin ophthalmic.The user was not using "protection".Product labeling states to wear protective gloves/ protective clothing/eye protection/face protection.

• Brand Name: ELECSYS SYSCLEAN
• 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: 8682499
• MDR Text Key: 147458558
• Report Number: 1823260-2019-02121
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: EC
• 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: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SYSCLEAN
• Device Catalogue Number: 11298500160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2019
• 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