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 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

1)the customer used all 5 tests in the box and threw away all of the materials, so we do not have the lot # for the test that the customer reported.Therefore, it is not possible to confirm the authenticity and effectiveness of the products used by customers 2)the customer did order 2 boxes at a time and provided the lot number for the second 5 pack that was shipped at the same time.It is possible that the two lots were the same.The lot # on the second 5 pack was 231co20829.3)test to lot:231co20829 batch of product retention samples,the test result is qualified.

Event Description

Event details: these tests do not work and were a waste of money.All 3 of us had covid and tested positive at a doctors office yet these test were negative.I tested 3 different days, twice before i went to the doctors office and once after having tested positive, and every one of them was negative but i was actually positive.After the other 2 family members also tested positive they also tested with these tests to see if just mine gave a false negative and sure enough theirs were also negative.These tests are extremely unreliable and again a waste of my money as i will not be using the other box that was also purchased because they result is unreliable.

• 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: 18738223
• MDR Text Key: 335823619
• Report Number: 3008573045-2024-00002
• 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: 02/20/2024

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: 02/07/2024
• Initial Date FDA Received: 02/20/2024
• 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