MAUDE Adverse Event Report: ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An anonymous consumer posted on twitter " this gives me so much anxiety.A few months ago in october i tested "positive" doing an oral swab with inteliswab.My pcr test was negative.And now i've been seeing posts that others experienced this and people are now saying this brand is known for false positves." oti marketing reponded to the consumer's post advising they contact oti via email (technicalservice@orasure.Com) so we can reach out to the directly for additional information.The consumer has not provided a lot number or any additional information.
Event or Problem Description
An anonymous consumer posted on twitter " this gives me so much anxiety.A few months ago in october i tested "positive" doing an oral swab with inteliswab.My pcr test was negative.And now i've been seeing posts that others experienced this and people are now saying this brand is known for false positives." oti marketing responded to the consumer's post advising they contact oti via email ((b)(6)) so we can reach out to the directly for additional information.The consumer has not provided a lot number or any additional information.
Additional Manufacturer Narrative
The consumer has not made any contact to date.The consumer did not provide a lot number or any additional information.No additional follow up is to be expected with this complaint and the incident will be closed internally.

• Brand Name: INTELISWAB COVID-19 RAPID TEST
• Common Device Name: INTELISWAB
• Manufacturer (Section D): ORASURE TECHNOLOGIES, INC.; 220 east first street; bethlehem PA 18015
• Manufacturer (Section G): ORASURE TECHNOLOGIES, INC.; 220 east first street; bethlehem PA 18015
• Manufacturer Contact: jennifer krause ; 220 east first street; bethlehem, PA 18015 ; 6108821820
• MDR Report Key: 19883192
• Report Number: 3004142665-2024-00021
• Device Sequence Number: 18520335
• Product Code: QKP
• Combination Product (Y/N): N
• PMA/510(K) Number: EUA210378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown