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U.S. Department of Health and Human Services

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

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RAPID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem False Negative Result (1225)
Patient Problem Fatigue (1849)
Event Date 10/02/2021
Event Type  malfunction  
Event Description
I have confirmed covid in (b)(6).I had absolutely positive contact again with covid patient in (b)(6) and became sick.The fatigue with covid and other symptoms were unmistakable but tested negative.For almost two weeks our family of five has been in quarantine, one child tested positive last week with covid via pcr.The rest of the house tested negative despite us all having symptoms.I fought acute hemorrhagic conjunctivitis with it all week this time and none still pcr came back negative again today.Neg rapid last week.The tests don't seem to be picking up covid with antibodies.I'm not on the level of illness i had in (b)(6), but the symptoms are still extremely fatigued, sinuses, stomach, etc i've never felt other than covid and mono.
 
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Brand Name
RAPID TEST
Type of Device
CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
MDR Report Key12583138
MDR Text Key275196162
Report NumberMW5104394
Device Sequence Number2
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 10/04/2021
2 Devices were Involved in the Event: 1   2  
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/05/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age44 YR
Patient Weight117
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