MAUDE Adverse Event Report: ELLUME LIMITED COVID-19 HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number M1025880

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

Patient Problems Headache (1880); Sore Throat (2396)

Event Date 10/18/2021

Event Type  malfunction  

Event Description

I purchased an ellume home covid test.Because i had a headache and sore throat, i took the test.I tested positive.I am contracted as an esl teacher for our district.I cancelled classes for the week.Because i am contracted, i do not get paid when i don't work.I called my primary care doctor.He told me to call my husband home from work.I went to a walk-in clinic and was tested.I tested negative.My primary care doctor did not believe the negative result."a positive result is a positive result," he said.I purchased another home test and it was also negative.Meanwhile, my positive result was called in to my school system, who has to do tracing.In addition, because we had a dinner party the night before, i had to report my result to my guests.One guest had to remove her child from daycare for the entire week.As you can see, it was an eventful week, and more than a little trouble was caused from this error.Fda safety report id # (b)(4).

• Brand Name: COVID-19 HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ELLUME LIMITED
• MDR Report Key: 12719358
• MDR Text Key: 279311468
• Report Number: MW5105010
• 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: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/04/2022
• Device Model Number: M1025880
• Device Catalogue Number: I-SRS-C-01
• Device Lot Number: PF03M-H
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 57