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U.S. Department of Health and Human Services

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

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COVID RAPID POINT OF CARE TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Test Result (2695)
Event Date 01/11/2021
Event Type  Injury  
Event Description
(b)(6) hospital conducted a false positive rapid covid test which prevented my cardiac catheterization and refused to repeat test. Had it repeated upon release and same type rapid test was negative 8 hours later and swab test was sent to lab. Results pending. Test repeated on my own after leaving hospital and it was negative, swab results pending. Will be in tonight. Picture included of my rapid and my pending results. Fda safety report id# (b)(4).
 
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Brand NameCOVID RAPID POINT OF CARE TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
MDR Report Key11193899
MDR Text Key227565704
Report NumberMW5098850
Device Sequence Number1
Product Code QKP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
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: 01/15/2021 Patient Sequence Number: 1
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