MAUDE Adverse Event Report: BIOLYTICAL LABORATORIES INC INSTI HIV-1/HIV-2 ANTIBODY TEST; INSTI HIV TEST

Model Number	90-1019
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause of the complaint was not determined.It is well documented in the ifu and a known limitation that using this device while on art that it could lead to performance issues with the devices.In this context, patient tested was known hiv positive.Initially it was understood that the patient was on art medication.However, after a second call with clinic it is unknown if the patient was taking art medication.No confirmatory tests was on the patient.This is a combined initial and final medical device report for this event.There won't be any additional follow-up reports to be submitted to this unless requested by the fda.
Event or Problem Description
Customer reported a false negative results with insti hiv-1/hiv-2 antibody test.Patient was known (b)(6).Initially it was understood that the patient was on art medication.However, after a second call with the clinic, it is unknown if the patient is taking art medication.

• Brand Name: INSTI HIV-1/HIV-2 ANTIBODY TEST
• Common Device Name: INSTI HIV TEST
• Manufacturer (Section D): BIOLYTICAL LABORATORIES INC; 13251 delf pl unit 406; richmond, british columbia V6V 2 A2; CA V6V 2A2
• MDR Report Key: 11838576
• Report Number: 3003871407-2021-00003
• Device Sequence Number: 4379315
• Product Code: MZF
• UDI-Device Identifier: 00686597010198
• UDI-Public: 00686597010198
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BP090032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2021

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: Health Professional
• Device Expiration Date: 04/21/2021
• Device Model Number: 90-1019
• Device Catalogue Number: 90-1019
• Device Lot Number: 1019200052
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 05/17/2021
• 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