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

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

Patient Problems Fatigue (1849); Headache (1880); Viral Infection (2248); Discomfort (2330); Sore Throat (2396); Cough (4457)

Event Date 01/17/2022

Event Type  malfunction  

Event Description

Hello, i think there may have been an issue with the early morning batch of tests at a drive thru site.My husband works at a prison and started with symptoms on sunday ((b)(6) 2022).He tested positive on 2 binax tests on sunday night.He may have started some mild symptoms before that, but got hit with a big headache sunday morning.Monday (b)(6) 2022 - i had scratchy throat.My son's nose started running just a little.I took a flowflex test in the evening and it was positive.Tuesday (b)(6) 2022 - i still have scratchy throat, son still has runny nose, gradually increasing every day.I took myself and both kids to a drive through pcr test at (b)(6) in (b)(6) first thing in the morning.My husband went to the same test site in the afternoon.Fast forward, friday (b)(6) 2022, my throat and fatigue are better, but have cough and congestion.Son's nose runny and coughing.Daughter asymptomatic or possibly a slight stomach discomfort in the morning.My husband got his pcr results back first, positive.At dinner time, i got mine and the kids pcr back - all 3 negative.I was very confused.I would have understood if just the kids were negative and say we did it too early, but i was symptomatic had tested positive on a home test approximately 12 hours before.I had 1 home kit left, so i used mucus from both me and my son and it came back positive right away.So i had some friends bring over some kits and tested us all 3 individually at bed time.Mine (inteliswab) and my sons (binax) both were positive.My daughter's (binax) was negative, but, we added the reagent (she may have used too much) and then i had to chase her around the house for at least 5 minutes before i could get the swab.The instructions say to insert the swab within 3 minutes, so that one was more likely to be wrong.Saturday (b)(6) 2022 - i took the kids for repeat pcrs.On the way home, i got some more flowflex tests at a drive through.I gave my daughter one (properly this time) around noon and it was positive.I feel like i should trust the pcrs more than the at homes, but they seem to be the outlier when other tests, exposures, and symptoms are considered.Thanks.Happy to discuss further.(b)(6).

• Brand Name: COVID-19 PCR
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• MDR Report Key: 13358419
• MDR Text Key: 284717770
• Report Number: MW5106961
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2022
• Patient Sequence Number: 1
• Treatment: VITAMINS
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White