MAUDE Adverse Event Report: COVID 19 SARS COV2 TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number 00000

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

Patient Problem Pneumonia (2011)

Event Date 10/19/2020

Event Type  Injury  

Event Description

I was diagnosed with covid 19 sars vo2 on (b)(6) 2020.I went back to (b)(6) urgent care (b)(6) 2020 to be retested and it was negative with a emergency referral to attend emergency.There it was determined i had pneumonia due to covid 19.The negative results does arise to a investigation because the swabbed testing was vague, it only went around the nose not inside to check all cells.Smart link order # (b)(4).Smark.Link fda safety report id# (b)(4).

• Brand Name: COVID 19 SARS COV2 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 10725932
• MDR Text Key: 212986936
• Report Number: MW5097408
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): Y
• 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: 10/21/2020

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
• Device Operator: No Information
• Device Expiration Date: 10/19/2020
• Device Model Number: 00000
• Device Catalogue Number: 1155574989
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 51 YR
• Patient Weight: 95