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U.S. Department of Health and Human Services

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

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RAPID COVID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
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).
 
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Brand NameRAPID COVID TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
MDR Report Key12312860
MDR Text Key266376341
Report NumberMW5103177
Device Sequence Number1
Product Code QKP
Number of Events Reported1
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 Received08/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/11/2021 Patient Sequence Number: 1
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