MAUDE Adverse Event Report: RT-PCR OR TMA; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

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

Patient Problem Test Result (2695)

Event Date 01/20/2021

Event Type  malfunction  

Event Description

Was tested on (b)(6) 2021 for covid 19 nasopharyngeal swab at (b)(6) in (b)(6).Three days later they call me for my results, they say i was positive.I thought it was wrong since i have been cooped up in my house the entirety of this time.Only went out when necessary.So, i got a second opinion and got three types of covid tests done, pcr, rapid and antibody on (b)(6) 2021 at (b)(6).All my results came back negative.I called to report to (b)(6) that they were wrong, and the person told me, "so what do you want me to do with that information?" so, i am reporting this because this needs to be recorded, and investigated in what is causing a false positive?.Fda safety report id # (b)(4).

• Brand Name: RT-PCR OR TMA
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• MDR Report Key: 11243302
• MDR Text Key: 229327306
• Report Number: MW5099040
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Weight: 57