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 01/08/2024

Event Type  malfunction  

Event Description

Event details: all of the tests in this package provided a false negative.It was ordered through amazon.I would like a return if possible.

Manufacturer Narrative

1)the customer used all 5 tests in the box and threw away all of the materials.The customer has not indicated why they think the tests results were false negative.Since these tests were ordered from amazon, an authorized agent of ihealth, there is no reason to believe that the tests were non-authentic.2)the customer has not responded to a request for additional information about why she thinks the results were false;the customer didn't pcr test ;results were compared using antigen reagents from different brands, but no relevant testing process or time was provided.3)test to lot: 231co20904 batch of product retention samples,the test result is qualified.

• 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: 18738202
• MDR Text Key: 335823613
• Report Number: 3008573045-2024-00003
• 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

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ICO-3000
• Device Lot Number: 231CO20904
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2023
• 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
• Patient Sex: Female