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

Catalog Number 1001-0622

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2024

Event Type  malfunction  

Event Description

The consumer called oti consumer support stating they received several inteliswab covid-19 rapid test kits from their local health department.The consumer stated test kits were received opened, with the tests out of the box, and missing the instructions and test stands.The consumer proceeded to use the inteliswab test kits and first received positive results but an hour later tested negative with another inteliswab test.The consumer performed 2 additional tests from another brand also showing negative results.The consumer did not provide details of how the test was performed or if the ifu was followed.It is unknown if a pcr test was taken to confirm the test results.

Event Description

The consumer called oti consumer support stating they received several inteliswab covid-19 rapid test kits from their local health department.The consumer stated test kits were received opened, with the tests out of the box, and missing the instructions and test stands.The consumer proceeded to use the inteliswab test kits and first received positive results but an hour later tested negative with another inteliswab test.The consumer performed 2 additional tests from another brand also showing negative results.The consumer did not provide details of how the test was performed or if the ifu was followed.It is unknown if a pcr test was taken to confirm the test results.

Manufacturer Narrative

The consumer reported false positive inteliswab test results but did not state if a confirmatory pcr test was performed.The consumer did not provide a phone number or email address for oti to perform a follow up.No additional follow up is to be expected with this complaint and the incident will be closed internally.

• 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: 18518657
• MDR Text Key: 332995445
• Report Number: 3004142665-2024-00001
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1001-0622
• Device Lot Number: CD220426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1