MAUDE Adverse Event Report: MAXIM BIOMEDICAL, INC. COVID-19 TEST KIT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number MB26MAY2201

Device Problems No Device Output (1435); Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 05/10/2023

Event Type  malfunction  

Event Description

A reporter called to report that she received 9 covid-19 test kits.She said her son and her used 4 out of 9 kits and none of them work.Reporter said the original expiration date was november 18, 2022 but it was extended to may 18, 2023.Ref reports: mw5117445, mw5117446, mw5117447.

• Brand Name: COVID-19 TEST KIT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): MAXIM BIOMEDICAL, INC.; 1500 east guide drive; rockville MD 20850
• MDR Report Key: 16910553
• MDR Text Key: 315090317
• Report Number: MW5117444
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/18/2023
• Device Lot Number: MB26MAY2201
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 59 KG