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

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.

• Brand Name: RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 12583138
• MDR Text Key: 275196162
• Report Number: MW5104394
• Device Sequence Number: 2
• Product Code: QKP
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 117