MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FOLATE III; FOLIC ACID TEST SYSTEM

Model Number	FOLATE G3
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Conjunctivitis (1784); Chemical Exposure (2570); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation is roche field application specialist (fas).Roche medical assessment states: tobramycin ophthalmic ointment is a topical antibiotic indicated where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.Eye tissue damage directed from outside by a splash of irritant substance affect primarily conjunctiva, cornea and anterior cavity.The initial injury may promptly get complicated by a secondary infection.Preventive administration of topical antibiotics is a reasonable medical measure widely followed.Benefit of preventive antibiotics outweighs the risk of complications due to infection.Product labeling provides the method of prevention: "wear protective gloves/protective clothing/eye protection/face protection." the investigation is ongoing.
Event or Problem Description
There was an allegation of an injury to the technician while checking for film on the elecsys folate iii (folate iii) reagent of a cobas e801 module serial number (b)(4).A film alarm occurred and the technician reportedly removed the reagent from the instrument to check for bubbles.While checking the reagent, the technician allegedly splashed the reagent in her eye.The technician was wearing gloves and a lab coat; she was not wearing face or eye protection.The technician flushed her eye with water and went to the urgent care center where they reportedly suggested she see an eye specialist.The technician reportedly saw an ophthalmologist who provided her with tobramycin eye ointment.The ophthalmologist allegedly discovered "damage" to her eye but did "not believe it is permanent." clarification was requested related to the alleged "damage" to the eye but the doctor "did not elaborate" on this statement.The technician is currently reportedly "doing ok" and is back at work.
Additional Manufacturer Narrative
The investigation determined the event was due to a product handling issue at the customer site.

• Brand Name: ELECSYS FOLATE III
• Common Device Name: FOLIC ACID TEST SYSTEM
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15188515
• Report Number: 1823260-2022-02366
• Device Sequence Number: 6493447
• Product Code: CGN
• UDI-Device Identifier: 04015630939695
• UDI-Public: 04015630939695
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2022

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
• Operator of Device: Health Professional
• Device Model Number: FOLATE G3
• Device Catalogue Number: 07027290190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female