MAUDE Adverse Event Report: INTRIVO ON/GO COVID-19 ANTIGEN SELF TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number RCPM-00279

Device Problems Crack (1135); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 01/22/2022

Event Type  malfunction  

Event Description

Five (5) in vitro diagnostic covid-19 antigen self-tests authorized under eua (b)(4) for home use were administered as directed on (b)(6) 2022 - (b)(6) 2022.Of these 5 tests (manufacturer: accessbio, distributor: (b)(4), ref: rcpm-00279, lot: cp21k21, exp: mar 2022) 4 showed invalid results, and all 5 failed to perform as expected (lateral flow test failed to run full distance of test strip).Upon inspection, the 5th test was found to have a crack near the center of the test strip.No damage was visible to the packaging at time of testing.Photos of 3 of the tests following completion of the 10 minute testing window are attached.Fda safety report id# (b)(4).

• Brand Name: ON/GO COVID-19 ANTIGEN SELF TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): INTRIVO; 2021 santa monica blvd, #11; santa monica CA 90404
• MDR Report Key: 13385438
• MDR Text Key: 284814075
• Report Number: MW5107036
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00860006191665
• UDI-Public: (01)00860006191665
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/25/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Model Number: RCPM-00279
• Device Lot Number: CP21K21
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female