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

Device Problem False Positive Result (1227)

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

Event Date 07/30/2020

Event Type  malfunction  

Event Description

Unnecessary isolation; i received a false positive from the quidel sofia sars cov-2 antigen rapid test.I was given this test at (b)(6), on (b)(6) 2020, and received a positive result.But a nasal sample taken for a pcr test on (b)(6) 2020 (through (b)(6)) delivered a negative result.This was confirmed by another pcr test on (b)(6) 2020 through (b)(6) hospital that was also negative.As a result of the positive result on the quidel antigen test, all close contacts were tested (nine family members) and all were negative.Fda safety report id# (b)(4).

• Brand Name: SOFIA SARS ANTIGEN FLUORESCENT IMMUNOASSAY
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 10395871
• MDR Text Key: 202725454
• Report Number: MW5096002
• 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: 08/08/2020

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR