MAUDE Adverse Event Report: COVID RAPID POINT OF CARE TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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

Patient Problem Test Result (2695)

Event Date 01/11/2021

Event Type  Injury  

Event Description

(b)(6) hospital conducted a false positive rapid covid test which prevented my cardiac catheterization and refused to repeat test.Had it repeated upon release and same type rapid test was negative 8 hours later and swab test was sent to lab.Results pending.Test repeated on my own after leaving hospital and it was negative, swab results pending.Will be in tonight.Picture included of my rapid and my pending results.Fda safety report id# (b)(4).

• Brand Name: COVID RAPID POINT OF CARE TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 11193899
• MDR Text Key: 227565704
• Report Number: MW5098850
• Device Sequence Number: 1
• Product Code: QKP
• 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: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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): Life Threatening
• Patient Age: 54 YR
• Patient Weight: 118