MAUDE Adverse Event Report: IHEALTH MANUFACTURING INC. IHEALTH COVID-19 TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number CVD2221206

Device Problem Component Missing (2306)

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

Event Date 06/06/2023

Event Type  malfunction  

Event Description

Ihealth covid-19 test lot no: cvd2221206, extraction reagent tube had no reagent solution.

• Brand Name: IHEALTH COVID-19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH MANUFACTURING INC.
• MDR Report Key: 17108112
• MDR Text Key: 317056351
• Report Number: MW5118312
• 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: 06/06/2023

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 Lot Number: CVD2221206
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2023
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White