MAUDE Adverse Event Report: ORASURE TECHNOLOGIES INC. ORAQUICK HCV RAPID ANTIBODY TEST; ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS

Lot Number	0006666212
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) health ((b)(6)) was identified to be using the oraquick hcv rapid antibody testing kit in oral manner and not by recommendations from the manufacturer for use in the united states, and only recommends using the fingerstick blood collection method.(b)(6) has stopped performing the test until further notice and is working with the (b)(6) department of health related to contacting the patients potentially impacted by this, who received a (b)(6) hcv result.(b)(6) is conducting this outreach and offering blood draws at the health center's (b)(6) location to all patients at no cost to the patient.All staff are undergoing training with the manufacturer and a new competency test is being identified.The manufacturer packaging is identical to the packaging for the kits allowed in eu to use in an oral manner and almost identical to the oraquick hiv rapid testing which is performed in an oral manner.The orasure, oraquick hcv test has been used at (b)(6) since at least 2015.We are currently in outreach with 622 patients identified to have received (b)(6) results during that timeframe, regardless of the manner in which the test was performed as some of the staff may have been using the fingerstick method.Route: using orally, not by mfr guidelines.Dates of use: 3.5 years.Diagnosis: use in pts with a risk for hepatitis c.

• Brand Name: ORAQUICK HCV RAPID ANTIBODY TEST
• Common Device Name: ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS
• Manufacturer (Section D): ORASURE TECHNOLOGIES INC.
• MDR Report Key: 8374064
• Report Number: MW5084411
• Device Sequence Number: 3014298
• Product Code: MZO
• UDI-Device Identifier: 00608337000535
• UDI-Public: 00608337000535
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Other
• Device Lot Number: 0006666212
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2019
• 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: Other