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

Catalog Number 1001-0616

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/23/2021

Event Type  malfunction  

Event Description

Consumer left a comment on (b)(6) stating: "i was tested positive today in a lab and took three of these tests that said negative.I am even symptomatic.".

Event Description

Consumer left a comment on (b)(6) stating: "i was tested positive today in a lab and took three of these tests that said negative.I am even symptomatic.".

Manufacturer Narrative

Consumer posted a review on facebook.Com.No follow up is to be expected with the complaint file and the incident will be closed internally.12/28/2021-corrected manufacturer report number to 3004142665-2021-00021.1/3/2022- added date of comment to b5.1/3/2022- corrected supplement 1.

Event Description

Consumer left a comment on facebook stating three of these tests gave them negative results while the lab test gave them postive results.On (b)(6) 2021: "i was tested positive today in a lab and took three of these tests that said negative.I am even symptomatic.".

• Brand Name: INTELISWAB COVID-19 RAPID TEST
• Type of Device: INTELISWAB
• Manufacturer (Section D): ORASURE TECHNOLOGIES INC.; 220 east first street; bethlehem OK 18015
• Manufacturer (Section G): ORASURE TECHNOLOGIES INC.; 220 east first street; bethlehem PA 18015
• Manufacturer Contact: jose rosado ; 220 east first street; bethlehem, PA 18015 ; 6108821820
• MDR Report Key: 13099101
• MDR Text Key: 286073896
• Report Number: 3004142665-2021-00021
• 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: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1001-0616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2021
• 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