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 01/20/2024

Event Type  malfunction  

Manufacturer Narrative

The customer has not indicated that she had a pcr confirmation of her covid diagnosis.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.

Event Description

Event details (z315370): i ordered/received the 5-pack of covid tests, because i had tested positive at a pharmacy and needed to be able to ascertain my health status to rejoin society.To test the product you sent me, i used it right after my (+) test, as a control, i tried to return this product on amazon and not able to.I used your product and followed the instructions exactly.I have used your tests before- no issues.However, with this box (5-pack), i received a false negative.I tested w another box/test kit immediately and got a positive twice in a row.I would like a refund for what i paid on amazon -- (b)(6).I do not need more tests as i have gotten over covid.Please advise on how i may receive my refund.

• 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: 18891609
• MDR Text Key: 337791061
• Report Number: 3008573045-2024-00008
• 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