MAUDE Adverse Event Report: SOFIA RAPID COVID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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

Patient Problem Test Result (2695)

Event Date 12/31/2020

Event Type  malfunction  

Event Description

On (b)(6) 2020 i had a sofia rapid covid test at an urgent care center.Showed up as positive.At the same time, they did a pcr test which was returned to me after 4 days with negative results.I confirmed with another rapid test done elsewhere on (b)(6) 2021 (also negative), and another pcr test done on (b)(6) 2021 (also negative).Fda safety report id # (b)(4).

• Brand Name: SOFIA RAPID COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 11163009
• MDR Text Key: 226784037
• Report Number: MW5098772
• Device Sequence Number: 1
• Product Code: QKP
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• 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
• Patient Age: 61 YR
• Patient Weight: 72