MAUDE Adverse Event Report: RAPID COVID TEST; REAGENT, CORONAVIRUS SEROLOGICAL

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

Patient Problem Test Result (2695)

Event Type  malfunction  

Event Description

I want to report a false negative with either the rapid covid test or the pcr covid test.I took a pcr 12 hrs after taking a rapid test and the pcr came back negative and the rapid came back positive.The tests shouldn't both be approved by the fda yet give contradicting results.Fda safety report id# (b)(4).

• Brand Name: RAPID COVID TEST
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• MDR Report Key: 11027203
• MDR Text Key: 222307125
• Report Number: MW5098411
• Device Sequence Number: 1
• Product Code: QKO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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 Age: 31 YR
• Patient Weight: 68