MAUDE Adverse Event Report: QUIDEL CORP. SOFIA SARS ANTIGEN FIA; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2020

Event Type  malfunction  

Event Description

I tested positive for sars cov 2 antigen using the sofia sars antigen fia on (b)(6) 2020 at (b)(6) healthy urgent care in (b)(6) 24 hours after developing itchy sore throat and cough.I am a physician and began 14 day quarantine.Pcr was sent out and results received (b)(6) 2020 were negative.Given concern for false positive due to mild symptoms and close contacts testing negative, i did have a rapid test performed by (b)(6) in (b)(6) on (b)(6) 2020, which was negative and pcr was sent out and still pending.I am still quarantined; however, i am questioning the validity of my original positive test using the sofia sars antigen fia.Please advise how i should proceed in dealing with this positive test and if the testing equipment could have been faulty in the urgent care operating room what the positive predictive value of this test is.I have missed 1 week of patient care and as i am an essential health care worker, i would like to have more information on this situation.Thank you.Fda safety report id# (b)(4).

• Brand Name: SOFIA SARS ANTIGEN FIA
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 10337810
• MDR Text Key: 201063956
• Report Number: MW5095751
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 67