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

Lot Number PF06QH

Device Problems Nonstandard Device (1420); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 11/20/2021

Event Type  malfunction  

Event Description

Bought 4 ellume covid tests.On this date, all four were recalled as defective.On (b)(6) 2021 completed all the requested documentation to ellume to receive new tests.On (b)(6) 2021 ellume said would send replacement.They have sent only one replacement despite repeated requests.

• Brand Name: COVID 19 HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ELLUME LIMITED
• MDR Report Key: 13505817
• MDR Text Key: 285564991
• Report Number: MW5107341
• Device Sequence Number: 2
• 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: 01/25/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: PF06QH
• Patient Sequence Number: 1
• Treatment: BABY ASPIRIN ; CALCIUM; LOSARTAN; ROSUVASTATIN
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White