MAUDE Adverse Event Report: QUIDEL CORP. QUIDEL'S RAPID ANTIGEN TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2020

Event Type  malfunction  

Event Description

My girlfriend's daughter was tested at (b)(6) urgent care to get a rapid test.Unfortunately, the test she received was quidel's rapid antigen test, which we have strong reason to believe gave a false positive test result.We will know for sure tomorrow when she receives her pcr test back; but everyone who has had contact with her tested negative.Two (2) places she could have gotten it, her classroom or her father's.Her mother (same day) - then pcr confirmed negative.Her sister - tested 2 days later and negative.All of the students and teachers that were in contact with her - so far - negative.Her father and his girlfriend - negative.I was negative.Etc.So either it's a false positive, or somehow it's not spreadable? fda safety report id # (b)(4).

• Brand Name: QUIDEL'S RAPID ANTIGEN TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 11036361
• MDR Text Key: 222637084
• Report Number: MW5098425
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 12/15/2020

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 YR