MAUDE Adverse Event Report: DNA GENOTEK ORE-100; ORAL SALIVA COLLECTION DEVICE

Catalog Number ORE-100

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146); Numbness (2415); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/16/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, a female individual contacted dna genotek regarding irritation in her mouth after swabbing her mouth with the ore-100 device for purposes of collecting a saliva sample for use with clarifi covid-19 testing in a school setting.The complaint was forwarded to quadrant biosciences on (b)(6) 2022.After reaching out to the individual, she indicated on (b)(6) 2022 the symptoms consisted of a burning sensation, tingling, numbness on the left side of her face, fatigue, stomach ache and headaches.The suspect medical device, ore-100, is used to collect saliva for use with the clarifi covid-19 test kit (b)(4).Ore-100 is manufactured by dna genotek and is included in the clarifi covid-19 test kit manufactured by quadrant biosciences as the device for collecting saliva specimens for testing with the clarifi test kit.In (b)(6) 2021, an individual swabbed the inside of her mouth using ore-100 for purposes of collecting a saliva sample for use with clarifi covid-19 testing in a school setting and experienced irritation.The individual contacted the dna genotek support team.Following the initial contact, the dna genotek team made several attempts to gather information from the individual with no response.On (b)(6) 2022, the complaint was forwarded to quadrant biosciences.After two attempts to gather information, the individual responded on (b)(6) 2022 that the symptoms they experienced in (b)(6) 2021 consisted of burning sensation, tingling and numbness on the left side of her face.The individual indicated after the first three occasions of administering the swab prior to (b)(6) 2021, the burning sensation, headache, fatigue and stomach ache experienced lasted for approximately 12 hours.When the individual administered the swab on (b)(6) 2021, they indicated the symptoms consisted of a burning sensation, tingling, numbness on the left side of her face, fatigue, stomach ache and headaches that lasted for two days, prompting her to contact her doctor.The doctor prescribed an epi pen as the individual does have preexisting latex sensitivity and chronic allergies.This submission is being made out of an abundance of caution, because medical intervention occurred and the potential severity of the individual's apparent reaction to contact with the ore-100 is unknown to the lack of any documented vital signs by the doctor, which would be used to predict the severity of the apparent reaction to the ore-100 to prompt the prescription of a safeguard in the event of the need for future medical intervention.

Manufacturer Narrative

Complaint was received by manufacturer, dna genotek on (b)(6) 2021.The complaint was forwarded to quadrant biosciences inc on (b)(6) 2022.

• Brand Name: ORE-100
• Type of Device: ORAL SALIVA COLLECTION DEVICE
• Manufacturer (Section D): DNA GENOTEK; 3000-500 palladium drive; ottawa, ontario K2V 1 C2; CA K2V 1C2
• Manufacturer (Section G): DNA GENOTEK; 3000-500 palladium drve; ottawa, ontario K2V 1 C2; CA K2V 1C2
• Manufacturer Contact: bryan greene ; 505 irving ave; suite 3100ab; syracuse, NY 13210 ; 3153824468
• MDR Report Key: 13660025
• MDR Text Key: 296762185
• Report Number: 3013712511-2022-00003
• Device Sequence Number: 1
• Product Code: OYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: ORE-100
• Device Lot Number: YD503
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female