MAUDE Adverse Event Report: CURATIVE / ABBOTT DIAGNOSTICS SCARBOROUGH, INC. COVID TEST / CURATIVE; REAGENT, CORONAVIRUS SEROLOGICAL

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

Patient Problem Insufficient Information (4580)

Event Date 08/19/2021

Event Type  malfunction  

Event Description

On thursday (b)(6) 2021 around 1:00pm pst, i received notification that i was exposed to a covid-19 positive individual.This individual is fully vaccinated with the pfizer covid vaccine, and their covid-positive test results were confirmed using the curative self-swab test.My family and i visited him for about an hour on (b)(6) 2021.Due to this exposure, i took a covid-19 test (oral swab) at (b)(6) in curative mobile truck on thursday (b)(6) 2021 around 2:00pm pst.On (b)(6) 2021 around 7:30am pst, i also tested using a color covid test kit (this self-swab nasal test is available through my employer (b)(6)).On (b)(6) 2021 around 4:30pm pst, my curative test results came back positive.About four hours later, just past 8:00pm pst, my color test came back negative on (b)(6) 2021, i contacted my employer at the (b)(6) covid hotline number to report these conflicting results.I was asked to come in for a 10:00am appointment covid test an oral-nasal swab to be administered by a nurse.My pcr test results came back negative.I was then put through their false-positive protocol where i had to take another covid test and an antibody igg nucleocapsid protein (serology) test the next day.I went to my appointment on (b)(6) 2021 for a 2nd covid test (oral-nasal swab by a nurse) and the serology test.My pcr test and antibody test results both came back negative.I contacted curative and asked them to update my covid positive status to negative and offered to provide documentation.I was transferred to their "escalation" team and was informed they cannot reverse my status but would accept any documentation i have.I was also informed that they "stand by their product".Fda safety report id # (b)(4).

• Brand Name: COVID TEST / CURATIVE
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): CURATIVE / ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 12412850
• MDR Text Key: 269825888
• Report Number: MW5103660
• Device Sequence Number: 1
• Product Code: QKO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1