MAUDE Adverse Event Report: RAPID COVID TEST; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Device Problem False Negative Result (1225)

Patient Problems Dyspnea (1816); Fatigue (1849); Headache (1880); Nausea (1970); Chills (2191); Sore Throat (2396); Cough (4457)

Event Date 08/25/2021

Event Type  malfunction  

Event Description

Covid tests: i have almost all of the symptoms of covid and have tested twice ("rapid test").I was led to believe covid tests were free, but after receiving a free test through (b)(6) with a negative test result, i was told my medical provider that i probably either tested too soon or that, also, the "rapid" covid tests that are not administered by clinics are "different/not as reliable".My medical provider said i should "be seen at the clinic"--not just tested-- had to be seen.After being "seen" at the clinic and having another negative "rapid" covid test result--the p.A.Wanted to do further extensive testing, including blood tests and the swab test that goes further up the nasal passage.None of these procedures are covered by my insurance.Although i know there are other viruses it could be, i reside in an area with high covid incidence and have been exposed to hundreds of people through my work.I have the sore throat, extreme cough with some difficulty at night breathing, i have lost sense of smell and taste, headache, fatigue, nausea, chills, nasal drainage.Why put out "free" tests that most likely will not detect variants, while covid variants are increasing? so with two negative tests, am i supposed to go back to work, while i am convinced it is most likely a covid variant? fda safety report id # (b)(4).

• Brand Name: RAPID COVID TEST
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• MDR Report Key: 12384262
• MDR Text Key: 268928369
• Report Number: MW5103546
• Device Sequence Number: 1
• Product Code: QJR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/25/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1