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 09/25/2022

Event Type  malfunction  

Event Description

The following comment was left on an orasure technologies, inc.Inteliswab facebook post: (b)(6).'my home test wrong both times said negative and i had it'.

Event Description

The following comment was left on an orasure technologies, inc.Inteliswab facebook post: (b)(6).'my home test wrong both times said negative and i had it'.

Manufacturer Narrative

Consumer posted a comment on facebook.Com with no personal information.No additional follow up is to be expected with the complaint file, 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: 15487342
• MDR Text Key: 306419910
• Report Number: 3004142665-2022-00030
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• 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: 09/26/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 09/26/2022
• Supplement Dates FDA Received: 09/27/2022
• 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