MAUDE Adverse Event Report: SARS- COV-2 AMPLIFICATION TEST; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Device Problem False Positive Result (1227)

Patient Problem Emotional Changes (1831)

Event Date 10/31/2021

Event Type  malfunction  

Event Description

Caused me severe stress.Hi this is (b)(6) i am reaching out because i would like to know what protocol is when receiving a false positive test result? on friday (b)(6) i received a pcr test with my spouse.The results came in on sunday (b)(6) mine was positive and my spouse was negative.I then immediately called out of work and scheduled a rapid test for the same day at 8am which came back negative.I called the place in which i was tested they informed me as long as i have a negative test result that i would be allowed to work.So i then went in for the rest of my shift.I received another pcr test monday (b)(6) which then came back negative yet again.I called the public health department as well as the place i got tested they informed me that as long as i had negative test results i would be allowed to return back to work, that my employer would not be notified.Friday (b)(6) the public health department notified my employer stating they had called me and informed me that i was positive and told me to self quarantine which is not true.I reached out to the public health department and not once have they reached out to me stating i needed to self quarantine or that i was positive.I then informed my employer that i had two negative test results and that the public health department as well as the place i got tested said i would be allowed to return back to work as long as i had negative test results.However that wasn't the case and my employer forced me to stay home due to the fact of what the public health department told him which was false information.I am highly upset i spent 4 1/2 hours on the phone with the place i got tested just to speak to a supervisor on friday (b)(6) nobody knew any answers and only informed me that when they receive and inconclusive test they have the patient retest.I said i did that already that what is the next step they said there wasn't one that they only just have them retest and asked if i wanted to get retested again.I emailed the supervisor of the public health department in regards as to what protocol was and if i would be able to get a reimbursement for my covid test a few days or so prior to public health department reaching out to my employer, stating the same information as i had stated above.The supervisor didn't inform me of self quarantining once so ever and said he would look into reimbursement and never reached back out to me.But yet they still called my employer stating i was positive which wasn't the case.False positive test result information: test ordered: sars- cov-2 amplification test.Type of test: anterior nares (in media).Order #: (b)(4).Collected: on (b)(6) 2021 at 5:30pm results: received on (b)(6) 2021 positive (pcr test).Negative test result information: test ordered: covid-19 rapid antigen (sars-cov-2) type of test: virus.Order #: (b)(4) collected: on (b)(6) 2021 at 8:49 am.Result: received on (b)(6) 2021 9am negative (rapid test).Test ordered: sars-cov2 amplification test.Type of test: anterior nares( in media).Order #: (b)(4) collected: on (b)(6) 2021 at 11:31 am.Result: received on (b)(6) 2021 negative (pcr test).(b)(6).Fda safety report id # (b)(4).

• Brand Name: SARS- COV-2 AMPLIFICATION TEST
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• MDR Report Key: 12786891
• MDR Text Key: 280712928
• Report Number: MW5105223
• 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: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: ADVIL PEPTO
• Patient Outcome(s): Other
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Hispanic
• Patient Race: White