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 01/04/2024

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((b)(4)): 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, assuming a (+) test result.No, it tested (-).So, i used another of your tests, and one more.All 3 gave false negative results while i was actively infected, sick in bed.

• 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: 18891608
• MDR Text Key: 337757331
• Report Number: 3008573045-2024-00007
• 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

• 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
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/12/2024
• 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: 35 YR