MAUDE Adverse Event Report: ANDON MEDICAL CO.,LTD IHEALTH; COVID-19 ANTIGEN RAPID TEST

Model Number ICO-3000

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem Insufficient Information (4580)

Event Date 06/11/2022

Event Type  malfunction  

Event Description

Complaint information: ordered two cases of 180 ihealth covid-19 antigen tests from sunline supply for use by our theatreemployees.Our covid compliance officer reported that 45% of the tests from sunline supply cameout blank, with no control line, and many had reagent tubes that were empty.

Manufacturer Narrative

1.The customer does not provide specific batch information, and cannot confirm the true condition of the product or test the reserved sample.2.Customers buy through sunline(https://sunlinesupply.Com/shop/test-kits/covid-otc-rapid-antigen-test-kitsihealth-box-of-2-tests-carton/), but sunline did not obtain ihealth's authorization to distribute ihealth products in the us.3.Ihealth labs demand that sunline supply immediately:1.Remove ihealth covid-19 antigen rapid test on your website;2.Provide information regarding your supplier of ihealth covid-19 antigen rapid test, including but not limited to, any transaction documents, shipping documents, communication records, etc.3.Provide your inventory records (number of test kits related to each lot#).

• Brand Name: IHEALTH
• Type of Device: COVID-19 ANTIGEN RAPID TEST
• 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: 14875152
• MDR Text Key: 303296266
• Report Number: 3008573045-2022-00136
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00208563205894
• UDI-Public: 208563205894
• 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: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• 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: 06/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: MW5110301
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male