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 02/20/2024

Event Type  malfunction  

Event Description

A consumer reported false positive inteliswab test results to oti consumer support.The consumer stated they performed two inteliswab tests on the same day, following all instructions, and both showed positive test results.The consumer then went to a clinic and received negative test results.The consumer did not provide details of the type of test performed at the clinic.It is unknown if a pcr test was taken to confirm the test results.The consumer's claim of 2 false positive test results using inteliswab tests are considered separate reportable events and will be investigated and reported separately.Refer to mfr report# 3004142665-2024-00004 for the first false positive test result.

Event Description

A consumer reported false positive inteliswab test results to oti consumer support.The consumer stated they performed two inteliswab tests on the same day, following all instructions, and both showed positive test results.The consumer then went to a clinic and received negative test results.The consumer did not provide details of the type of test performed at the clinic.It is unknown if a pcr test was taken to confirm the test results.The consumer's claim of 2 false positive test results using inteliswab tests are considered separate reportable events and will be investigated and reported separately.Refer to mfr report# 3004142665-2024-00004 for the first false positive test result.

Manufacturer Narrative

The consumer reported false positive inteliswab test results but did not state if a pcr test was performed confirming the false positive test results.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: 18768879
• MDR Text Key: 336964220
• Report Number: 3004142665-2024-00005
• 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: 03/07/2024

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: CD220279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/30/2022
• 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