MAUDE Adverse Event Report: ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST

Catalog Number 1001-0622

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 05/14/2022

Event Type  Injury  

Manufacturer Narrative

Date of medwatch report mw5109755 was noted to be (b)(4) 2022.Consumer provided the lot number of the inteliswab test kit (21036-01x) and expiration date is 03/22/2022.Consumer did not provide date they used the inteliswab tests.

Event Description

Oti received medwatch report mw5109755, via email from the fda.Consumer voluntarily submitted the mdr for inteliswab.Consumer stated after using inteliswab they started having sinus, headache, bloody nose and ear pain.Consumer stated the symptoms would last the remainder of test day, the following day and on the third day only a little remainder of blood remained in the nose.Consumer stated they used the test exactly as described in the instructions except the consumer was only required to use one swab in the kit per week as long as they tested negative.Consumer took a total of 5 tests.As the covid levels went down in the community, the consumer stopped testing.

Manufacturer Narrative

5/20/22-date of medwatch report mw5109755 was noted to be 5/14/2022.Consumer provided the lot number of the inteliswab test kit (21036-01x) and expiration date is 03/22/2022.Consumer did not provide date they used the inteliswab tests.6/6/2022- oti emailed consumer on 5/31/2022 to gather more information about the event.The consumer stated they used the inteliswab test prior to expiry.The consumer stated that they went to the (b)(6) hospital emergency room on (b)(6) 2022 to report symptoms of headache, burning in nose and ear pain.Consumer received a dr.Note to abstain from testing with a nasal swab and to request an alternate saliva test.The consumer stated they performed the test using the instructions on the package insert.Currently oti is evaluating changing the inteliswab ifu to reduce risk of future events.At this time, no further information is expected by this consumer in order to continue an investigation.This complaint file will be closed internally.

Event Description

Oti received medwatch report mw5109755, via email from the fda.Consumer voluntarily submitted the mdr for inteliswab.Consumer stated after using inteliswab they started having sinus, headache, bloody nose and ear pain.Consumer stated the symptoms would last the remainder of test day, the following day and on the third day only a little remainder of blood remained in the nose.Consumer stated they used the test exactly as described in the instructions except the consumer was only required to use one swab in the kit per week as long as they tested negative.Consumer took a total of 5 tests.As the covid levels went down in the community, the consumer stopped testing.

• Brand Name: INTELISWAB COVID-19 RAPID TEST
• Type of Device: INTELISWAB
• Manufacturer (Section D): ORASURE TECHNOLOGIES, INC.; 220 east first street; bethlehem PA 18015
• Manufacturer (Section G): ORASURE TECHNOLOGIES, INC.; 220 east first street; bethlehem PA 18015
• Manufacturer Contact: jennifer krause ; 220 east first street; bethlehem, PA 18015 ; 6108821820
• MDR Report Key: 14465243
• MDR Text Key: 292392973
• Report Number: 3004142665-2022-00023
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/22/2022
• Device Catalogue Number: 1001-0622
• Device Lot Number: 21036-01X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male