MAUDE Adverse Event Report: RAPID COVID-19; REAGENT, CORONAVIRUS SEROLOGICAL

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

Patient Problem Virus (2136)

Event Date 07/01/2020

Event Type  malfunction  

Event Description

My son tested negative in (b)(6) 2020 worth the rapid covid-19 test at medical access in (b)(6) but we received a positive test result from the lab and swab taken on (b)(6).Fda safety report id# (b)(4).

• Brand Name: RAPID COVID-19
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• MDR Report Key: 10270070
• MDR Text Key: 198880764
• Report Number: MW5095498
• Device Sequence Number: 1
• Product Code: QKO
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• 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: 17 YR
• Patient Weight: 75