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

Device Problem False Positive Result (1227)

Patient Problem Convulsion/Seizure (4406)

Event Date 08/01/2021

Event Type  malfunction  

Event Description

False positive covid test; my daughter was checked into er for a febrile seizure last week.Not something uncommon for her before covid ever came about.She was tested with a rapid test which came back with a false positive.She showed no signs of covid, and was retested 6 days later through a regular testing site where she, myself, and her father all tested negative.How are false positives handled and corrected in order to keep the most accurate information? fda safety report id # (b)(4).

• Brand Name: RAPID COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 12312860
• MDR Text Key: 266376341
• Report Number: MW5103177
• Device Sequence Number: 1
• Product Code: QKP
• 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: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other