MAUDE Adverse Event Report: ORASURE TECHNOLOGIES, INC. IN-HOME HIV TEST ORAQUICK; HIV SELF-TESTS

Lot Number	006711890A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Received a false positive test result on an oraquick in-home hiv test.Lot number 006711890a.Expiration date 2026-01-31.As far as i am aware i followed all instructions properly.I wanted to report this just to record in the field use fault of the product, in case the lot was contaminated/damaged before distribution.Also reported to oraquick company itself.

• Brand Name: IN-HOME HIV TEST ORAQUICK
• Common Device Name: HIV SELF-TESTS
• Manufacturer (Section D): ORASURE TECHNOLOGIES, INC.
• MDR Report Key: 20091242
• Report Number: MW5158927
• Device Sequence Number: 15371375
• Product Code: QSS
• UDI-Device Identifier: 00608337103403
• UDI-Public: 00608337103403
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2026
• Device Lot Number: 006711890A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ZYRTEC
• Patient Age: 24 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White