MAUDE Adverse Event Report: ANDON MEDICAL CO.,LTD IHEALTH; Coronavirus antigen detection test system.

Model Number ICO-3000

Device Problem False Negative Result (1225)

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

Event Date 02/09/2024

Event Type  malfunction  

Event Description

Event details((b)(4)): i purchased multiple 2 packs of these tests on amazon after my family initially tested positive for covid-19, and while retesting with one of the ihealth tests, following all directions properly, this test produced a false negative result when additional tests from other brands remained strong positives.I do not believe i can have any confidence in these ihealth tests as i continue to retest my family.I would like to request a refund for the tests i purchased and would be glad to provide any additional information necessary.Thank you.

Manufacturer Narrative

The customer has not indicated that had a pcr confirmation.No lot number provided,unable to effectively verify and confirm customer feedback.A false negative result may occur if the test result is read before 15 minutes or after 30 minutes.There was no indication to confirm or deny if the user/patient had utilized the test kit appropriately as per intended use or off use.

• Brand Name: IHEALTH
• Type of Device: Coronavirus antigen detection test system.
• Manufacturer (Section D): ANDON MEDICAL CO.,LTD; tianjin, airport economic area 30030 8; CH 300308
• Manufacturer (Section G): ANDON MEDICAL CO.,LTD; tianjin, airport economic area 30030 8; CH 300308
• Manufacturer Contact: ren jun ; tianjin, airport economic area 30030-8 ; CH 300308
• MDR Report Key: 18891607
• MDR Text Key: 337774605
• Report Number: 3008573045-2024-00009
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EUA210470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ICO-3000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR