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 10/30/2021

Event Type  malfunction  

Event Description

Consumer left a review on (b)(6) that they tested negative using inteliswab.Consumer went to the er to get tested and results were positive.(b)(6) review (b)(6) 2021 50% right on covid test tested negative.My husband was positive so we took him to the er.While there they tested us both again and we were both positive.50% isn't a very good average as to how your tests work.

Manufacturer Narrative

Consumer posted review on walgreens.Com.No followup is to be expected with the complaint file and the incident will be closed internally.Corrected the report to include the eua number, full device description name and a corrected phone number as requested.

Event Description

Consumer left a review on walgreens.Com that they tested negative using inteliswab.Consumer went to the er to get tested and results were positive.Walgreens.Com review 10/30/2021 50% right on covid test tested negative.My husband was positive so we took him to the er.While there they tested us both again and we were both positive.50% isn't a very good average as to how your tests work.

• 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: jose rosado ; 220 east first street; bethlehem, PA 18015 ; 6108821820
• MDR Report Key: 12727555
• MDR Text Key: 281027985
• Report Number: 3004142665-2021-00012
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2021

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 Catalogue Number: 1001-0616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2021
• Initial Date FDA Received: 11/01/2021
• Supplement Dates Manufacturer Received: 10/30/2021; 10/30/2021
• Supplement Dates FDA Received: 11/12/2021; 12/03/2021
• 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