MAUDE Adverse Event Report: BIOLYTICAL LABORATORIES INC. INSTI HIV1 HIV2 ANTIBODY TEST; HIV RAPID TEST

Model Number	90-1019
Health Effect - Clinical Code	HIV, Human Immunodeficiency Virus (2197)
Date of Event	07/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Testing with insti hiv took place in an outreach needle exchange site.The client tested (b)(6) with insti and refused follow up bloodwork.From the conversation the tester had with the client about the client's (b)(6) partner and the fact he shares needles etc., the tester was suspicious about the result and offered an additional test, which the client refused.The tester reviewed the client's details in their system and confirmed that he was a repeat visitor and had been sent for bloodwork by his (b)(6) care provider 18 months ago.The site also confirmed that this patient initially entered the system in 2008 as (b)(6) in the state of (b)(6).The site could not confirm if the client is on (b)(6).

• Brand Name: INSTI HIV1 HIV2 ANTIBODY TEST
• Common Device Name: HIV RAPID TEST
• Manufacturer (Section D): BIOLYTICAL LABORATORIES INC.; 1108, 13351 commerce parkway; richmond, british columbia V6V 2 X7; CA V6V 2X7
• MDR Report Key: 5990836
• Report Number: 3003871407-2016-00001
• Device Sequence Number: 13627854
• Product Code: MZF
• UDI-Device Identifier: 06865979010191
• UDI-Public: 06865979010191
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: BP090032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2016

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: Medical Technologist
• Device Expiration Date: 03/01/2017
• Device Model Number: 90-1019
• Device Catalogue Number: 90-1019
• Device Lot Number: 1602AB016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2016
• Initial Report FDA Received Date: 09/30/2016
• 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