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

Model Number GTIN: 20856362005894

Device Problems Product Quality Problem (1506); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 07/11/2022

Event Type  malfunction  

Event Description

One package of at-home covid test i received from.Gov did not work.Neither test shows a control line.Same package, used at the same time, on 2 different people.(marked l and r) gtin(01): 20856362005894 lot no.(10): 221co20221 use by(17): 2022-08-20 we just received these in the mail this past week.This is the free self-test sent from.Gov website.Fda safety report id # (b)(4).

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH
• MDR Report Key: 15015732
• MDR Text Key: 295958696
• Report Number: MW5110845
• 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: 07/11/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/20/2022
• Device Model Number: GTIN: 20856362005894
• Device Lot Number: 221CO20221
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2022
• Patient Sequence Number: 1