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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2024

Event Type  malfunction  

Event Description

An anonymous consumer posted on twitter stating, 'can anecdotally confirm that accuracy issue w/ intelliswab rats.Gave me my first false positive yesterday (oral/nasal combo swab.) disconfirmed with 2 negatives via at-home pcr (metrix, nasal, 30m later) and binax rat 24hrs later (triple swab.)' refer to the attached twitter post.Oti marketing department replied to the consumer's twitter post advising they email oti so we can reach out to them directly for additional information.As stated in the inteliswab covid-19 rapid test ifu, 'important: swabbing the nostrils is critical for obtaining an accurate result.If you do not swab your nose, the device will produce a false negative result.'.

Event Description

An anonymous consumer posted on twitter stating, 'can anecdotally confirm that accuracy issue w/ intelliswab rats.Gave me my first false positive yesterday (oral/nasal combo swab.) disconfirmed with 2 negatives via at-home pcr (metrix, nasal, 30m later) and binax rat 24hrs later (triple swab.)' refer to the attached twitter post.Oti marketing department replied to the consumer's twitter post advising they email oti so we can reach out to them directly for additional information.As stated in the inteliswab covid-19 rapid test ifu, 'important: swabbing the nostrils is critical for obtaining an accurate result.If you do not swab your nose, the device will produce a false negative result.'.

Manufacturer Narrative

The consumer commented on twitter reporting false positive inteliswab test results only while using the device against the ifu.Oti marketing responded to the consumer's twitter comment advising them to email more information to technicalservice@orasure.Com.The consumer has not provided a lot number or any additional information to date.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: 18888008
• MDR Text Key: 337564862
• Report Number: 3004142665-2024-00009
• 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: 04/11/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 04/11/2024
• 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: Unknown
• Patient Sequence Number: 1