MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PROCELL ELECSYS,COBAS E; GENERAL PURPOSE REAGENT

Catalog Number 11662988122

Device Problem Device Handling Problem (3265)

Patient Problem Irritation (1941)

Event Date 08/14/2017

Event Type  Injury  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).For the cleancell reagent, the following information applies to each corresponding medwatch field: brand name: cleancell elecsys,cobas e.Catalog number: 11662970122.Lot number: 15562401.Expiration date: 28-feb-2018.

Event Description

During weekly maintenance of the cobas 8000 e 602 module (e602), the operator was replacing the reservoirs for the elecsys procell (procell) and elecsys cleancell (cleancell) system reagents.Some of either the procell or cleancell reagent splashed into the operator's eye, which led to irritation of the eye.The operator was not wearing safety glasses at the time of the event.The operator immediately flushed her eyes with water, but the irritation persisted.The operator visited a doctor who prescribed a treatment of eye drops to her.It was asked, but the specific eye drops used for treatment is unknown.The operator currently feels good and has resumed work duties.As the operator did not wear safety glasses when changing the procell and cleancell system reagents, the operator did not follow the warning and prevention details provided in procell and cleancell product labeling.

Manufacturer Narrative

The eye drop medication prescribed to the operator was co-avazir (tobramycin 0.3% / dexamethasone 0.1%).

• Brand Name: PROCELL ELECSYS,COBAS E
• 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: 6854586
• MDR Text Key: 85636823
• Report Number: 1823260-2017-01939
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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,Followup
• Report Date: 09/13/2017

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 Expiration Date: 03/31/2018
• Device Catalogue Number: 11662988122
• Device Lot Number: 15985901
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 09/11/2017
• Supplement Dates Manufacturer Received: 08/14/2017
• Supplement Dates FDA Received: 09/13/2017
• 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): Required Intervention