MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. COVID-19 ANTIGEN SELF-TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 2204634EUA

Device Problem Expiration Date Error (2528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2023

Event Type  malfunction  

Event Description

I received new at-home covid tests from siemens/clinitest on (b)(6) 2023.The tests show a use by date of 2023-02.Lot is 2204634eua.The lot number is not listed on the covid site for extended use by dates.It appears the company is shipping expired tests.

• Brand Name: COVID-19 ANTIGEN SELF-TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.
• MDR Report Key: 16911086
• MDR Text Key: 315114985
• Report Number: MW5117456
• 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: 05/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/28/2023
• Device Lot Number: 2204634EUA
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2023
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White