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

Device Problem Nonstandard Device (1420)

Patient Problems Dyspnea (1816); Muscle Weakness (1967); Pneumonia (2011); Cough (4457)

Event Date 01/03/2022

Event Type  Death  

Event Description

My father, (b)(6) arrived at the er at (b)(6) hospital in (b)(6).My brother drove my ill dad there and i accompanied him there.I grab a wheelchair for my dad since he is too weak to walk.My bother helps me transfer him from van seat to wheelchair.We go in my father and i and are stopped by to get checked.They ask us what are the symptoms.I tell the lady that he is weak, can't breath, and has a bit of a cough.He understands a bit of english only.So, i am there to translate and i am the one that used to help him.When i mention those symptoms they rush us to a secluded room where he and i are the only ones.After a bit a person calls my dad and takes us to an er room.The triage nurse comes in and immediately says it's covid.They do all sorts of test and the covid test came out negative.They did the test 4 times and they were all negative.He was still treated as a covid patient.He was transferred to a room in the second floor of (b)(6) and was given antibiotics.Was all normal.The week went by and i asked about what the plan was.The nurse simply responded by say that it was covid and there was really no protocol for that.Since it is rural hospital there is no pulmonologist onsite.The doctor would come in the morning and talk to my dad.Sometimes they would set up a translator monitor and sometimes not.I couldn't go because visit hours were from 2pm-6pm for covid patients.It was an hour only stay but i stayed the whole time.I visited him everyday.I used to help him and i help my mother out as well.A week turned to two and nothing else was said besides covid.He got regular meds for bed riden patients.No pulmonologist just x-rays and ct scans.Also, oxygen is turned up because he is having trouble breathing.He is pretty much bedridden.By the third week i call to see his progress since i can't go in.I am told that he is in icu.I go in at 2pm and dr.(b)(6) comes in a says he is in bad shape.He says he will pretty much stay there and die there.I ask about a transfer and he says that can't happen since he has covid because his ctscan and x-rays show covid lungs even though covid tests were all negative.By this time he is pretty weak.He leaves and dr.(b)(6) takes over.He is a bit more optimistic.He tells me that his lungs look a bit better and that he will give my dad a covid medication.Never knew if that happened.By the fourth week he is just looking worse.They scare us at least three time that he will pass away.He is malnourished and he begs to be transferred.This is his second time asking.Dr.(b)(6) and tge charge rn at the icu, (b)(6) who knows (b)(6) and translates for my mom and dad say no.They say that there are no beds available in the area, (b)(6), (b)(6) hospital.Also, they mentioned that no one will take him because he has covid.Yet, we are all geared up with covid protection and they never are.He leaves and dr.(b)(6) step in, by this time he is just making it but my dad keeps fighting.I come in and my dad is frantic.He tell me they are going to kill him, he tells me to get him out of there.I tell the rn that i need to talk to the doctor.Dr.(b)(6) calls me and i voice my concern.She tells me again that he can't be transferred.Why? because he is a covid patient and there are no beds anywhere in the area.The nurse right way gives him a sedative and my dad says in (b)(6), "again with that drug stuff." he falls asleep.Still nothing has been said about pneumonia since that is what he is diagnosed with.I am desperate at this time.I am contacting people left and right.This is the fourth week now and the nurses are not liking the fact that i go everyday, essentially after i question the doctor and want answers.I keep calling after visiting hours and by this time my calls just stop at the front desk of icu, the nurses don't contact me.At the beginning the calls would go through they do procedures at night, dr.(b)(6) again tells me he won't make it.I contact the hospital (b)(6) and send them an email and voice my concern.And ask for help, a cno comes in and tells the same thing.He is intubated without our consent and the ventilator is recalled.It is a puritan bennett 980.His hands are tied down.I finally contact our state rep., they advocate for us.And that is when he is transferred.It is another branch of (b)(6) in (b)(6).He dies there.He is buried in (b)(6) because we are too far from home and our relatives are there.Now my mom had a massive stroke after his bural (b)(6) 2022.She enters (b)(6) hospital in (b)(6) on thursday, (b)(6) 2022.She is also fighting for her life.Fda safety report id #:(b)(4).

Event Description

My father, (b)(6) arrived at the er at (b)(6) hospital in (b)(6).My brother drove my ill dad there and i accompanied him there.I grab a wheelchair for my dad since he is too weak to walk.My bother helps me transfer him from van seat to wheelchair.We go in my father and i and are stopped by to get checked.They ask us what are the symptoms.I tell the lady that he is weak, can't breath, and has a bit of a cough.He understands a bit of english only.So, i am there to translate and i am the one that used to help him.When i mention those symptoms they rush us to a secluded room where he and i are the only ones.After a bit a person calls my dad and takes us to an er room.The triage nurse comes in and immediately says it's covid.They do all sorts of test and the covid test came out negative.They did the test 4 times and they were all negative.He was still treated as a covid patient.He was transferred to a room in the second floor of (b)(6) and was given antibiotics.Was all normal.The week went by and i asked about what the plan was.The nurse simply responded by say that it was covid and there was really no protocol for that.Since it is rural hospital there is no pulmonologist onsite.The doctor would come in the morning and talk to my dad.Sometimes they would set up a translator monitor and sometimes not.I couldn't go because visit hours were from 2pm-6pm for covid patients.It was an hour only stay but i stayed the whole time.I visited him everyday.I used to help him and i help my mother out as well.A week turned to two and nothing else was said besides covid.He got regular meds for bed riden patients.No pulmonologist just x-rays and ct scans.Also, oxygen is turned up because he is having trouble breathing.He is pretty much bedridden.By the third week i call to see his progress since i can't go in.I am told that he is in icu.I go in at 2pm and dr.(b)(6) comes in a says he is in bad shape.He says he will pretty much stay there and die there.I ask about a transfer and he says that can't happen since he has covid because his ctscan and x-rays show covid lungs even though covid tests were all negative.By this time he is pretty weak.He leaves and dr.(b)(6) takes over.He is a bit more optimistic.He tells me that his lungs look a bit better and that he will give my dad a covid medication.Never knew if that happened.By the fourth week he is just looking worse.They scare us at least three time that he will pass away.He is malnourished and he begs to be transferred.This is his second time asking.Dr.(b)(6) and tge charge rn at the icu, (b)(6) who knows (b)(6) and translates for my mom and dad say no.They say that there are no beds available in the area, (b)(6), (b)(6) hospital.Also, they mentioned that no one will take him because he has covid.Yet, we are all geared up with covid protection and they never are.He leaves and dr.(b)(6) step in, by this time he is just making it but my dad keeps fighting.I come in and my dad is frantic.He tell me they are going to kill him, he tells me to get him out of there.I tell the rn that i need to talk to the doctor.Dr.(b)(6) calls me and i voice my concern.She tells me again that he can't be transferred.Why? because he is a covid patient and there are no beds anywhere in the area.The nurse right way gives him a sedative and my dad says in (b)(6), "again with that drug stuff." he falls asleep.Still nothing has been said about pneumonia since that is what he is diagnosed with.I am desperate at this time.I am contacting people left and right.This is the fourth week now and the nurses are not liking the fact that i go everyday, essentially after i question the doctor and want answers.I keep calling after visiting hours and by this time my calls just stop at the front desk of icu, the nurses don't contact me.At the beginning the calls would go through they do procedures at night, dr.(b)(6) again tells me he won't make it.I contact the hospital (b)(6) and send them an email and voice my concern.And ask for help, a cno comes in and tells the same thing.He is intubated without our consent and the ventilator is recalled.It is a puritan bennett 980.His hands are tied down.I finally contact our state rep., they advocate for us.And that is when he is transferred.It is another branch of (b)(6) in (b)(6).He dies there.He is buried in (b)(6) because we are too far from home and our relatives are there.Now my mom had a massive stroke after his bural (b)(6) 2022.She enters (b)(6) hospital in (b)(6) on thursday, (b)(6) 2022.She is also fighting for her life.Fda safety report id #:(b)(4).

• Brand Name: COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 13599786
• MDR Text Key: 286258654
• Report Number: MW5107696
• Device Sequence Number: 2
• Product Code: QKP
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 02/22/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Death
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Hispanic
• Patient Race: White