MAUDE Adverse Event Report: COVID 19 TEST; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Chest Pain (1776); Diarrhea (1811); Fatigue (1849); Fever (1858); Vomiting (2144); Swollen Lymph Nodes/Glands (4432); Cough (4457)

Event Date 11/09/2021

Event Type  malfunction  

Event Description

I and my son received the covid 19 test i had 2 so far and know fact i got false negative result and my son had false negative result.My mother is positive shortly after coming near us after we supposedly tested negative.Also the nurse told us oh it's okay to be positive and still go to work.Work through it.She did.She is from (b)(6) hospital.Short red hair, heavy set.She also lied on the drs notes saying we didn't look sick and didn't apply her name to the chart.The dr felt my throat and said girl you are sick.I also have a fever of 102.3.The nurse also told me go to one of their 500 other places for a covid test it's not that serious.Well the dr told us good thing we came to the er.My son and i both have asthma and our chests hurt, our lungs hurt.My son was prescribed medication.Both coughing up thick, nasty flem, throwing up, stomachs hurt, body hurts, tired, high fevers, the poops.Every single symptom on the list.We are both at home staying away from the public.The nurse needs reported as she is spreading covid in the er and openly admitted it.Her boss (b)(6) was sitting right there of (b)(6) hospital.It was at 2:30pm on tuesday.The boss didn't say a word to the ignorant nurse.No wonder people are afraid of going to the drs or er.My son was told go to the er for his trouble breathing and that nurse took it as if it was a joke.She also lied in her notes on our chart.There is none of those listed for the test in my side of my chart app.For neither one of myself or my son.Fda safety report id # (b)(4).

• Brand Name: COVID 19 TEST
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• MDR Report Key: 12820427
• MDR Text Key: 280934893
• Report Number: MW5105341
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• 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: 11/11/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White