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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anxiety (2328); Depression (2361)

Event Description

Test results not available after several days.My child has been isolated in her room possibly unnecessarily because the results aren't in yet.She has anxiety and depression and this is making it worse.There's no way to report the issue to the company.Waited in the car in line for 7.5 hours with no food to get tested.Test results are past due and cannot reach anyone on the phone.When selecting option for results it's hangs up on you.After waiting on hold for an hour to schedule, they hang up on you.My child has been isolated in her room possibly unnecessarily because the results aren't in yet.This is unacceptable.

• Brand Name: COVID 19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 13168221
• MDR Text Key: 283336456
• Report Number: MW5106444
• Device Sequence Number: 1
• Product Code: QKP
• 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
• Type of Report: Initial
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: AYEGESTIN ; CALCIUM; LUPRON; PROAIR INHALER ; ZINC
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American