MAUDE Adverse Event Report: ANDON MEDICAL CO., LTD IHEALTH COVID-19 ANTIGEN RAPID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number ICO-3000

Device Problems Product Quality Problem (1506); Component Missing (2306)

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

Event Date 06/13/2022

Event Type  malfunction  

Event Description

No diluent/sterile media provided to conduct testing for kits, multiple packages.Brand: ihealth model: ico-3001, lot no.(10): 223co20214, exp:2022-08-13.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): ANDON MEDICAL CO., LTD
• MDR Report Key: 14695020
• MDR Text Key: 294385976
• Report Number: MW5110304
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00856362005890
• UDI-Public: 856362005890
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/13/2022
• Device Model Number: ICO-3000
• Device Lot Number: 223CO20214
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White