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

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

The consumer left a message on the inteliswab.Com chatbot feature on 11/30/2022 stating that they received a negative result using inteliswab and a positive result with another test.Orasure technologies has chosen to report the consumer's complaint.The consumer has been contacted to provide additional information on whether a pcr test was taken to confirm the negative result obtained using inteliswab.If additional information is obtained from the consumer, this final report will be updated to reflect the additional information.

Event Description

Consumer left a comment on the inteliswab.Com chatbot feature.Message: i tested positive on another test named quick vue, and shortly tested with inteliswab and my test came out negative.With what test should i go with ?.

Event Description

Consumer left a comment on the inteliswab.Com chatbot feature.Message: i tested positive on another test named quick vue, and shortly tested with inteliswab and my test came out negative.With what test should i go with ?.

• 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: 15919663
• MDR Text Key: 307920619
• Report Number: 3004142665-2022-00042
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): Y
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: No
• 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