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

Model Number ICO-3000

Device Problem False Negative Result (1225)

Patient Problems Dyspnea (1816); Tachycardia (2095); Malaise (2359); Unspecified Respiratory Problem (4464)

Event Date 09/24/2023

Event Type  malfunction  

Manufacturer Narrative

1.Checked the lot number expiration date and any suspicious reports: tests are not expired and there is no history or suspicious activity on the lot number provided by the customer.2.Test to the production batch of product retention samples (lot: 221co20815), the test result was pass.3.Communication: since the customer provided their contact details, we opened zendesk ticket (b)(4).In this ticket, we have summarized the complaint and asked the complainant to verify the information in the complaint.We have also requested that the complainant provide the following information: confirm the lot number and any other lot numbers that may be involved provide photos of the outer box (the carton) and the front and back of the individual test kit packaging box.Where did you purchase/obtain the test kit? do you have the seller receipt or order number for the purchase?: we have reached out to the customer via email through zendesk on 9/26/2023 and 9/28/2023.The customer has not yet responded.We will continue to reach out to the customer.4.Mw5145015 /mw5145016 /mw5145017 were the same issue reported by the same customer.

Event Description

I, and my houseguests (one with partial sci, chronic low immunity who has been extra careful to avoid exposure) were most likely exposed to an employee of (b)(6) who had tested negative using their antigen kits, was asymptomatic at the time of a shared dinner (and continued negative on serial antigen testing with kits supplied by (b)(6)).That date: friday, (b)(6) 2023.She called to let us know that she had the symptoms, gave us the choice to decline dinner together and said her antigen testing was negative (as were her colleagues with similar symptoms).The dinner guest experienced flu-like symptoms the next day, managed with dayquil and nyquil.My houseguests and i had very limited / no exposure to the community for 10 days (the wife and i went grocery shopping one day).One of my houseguests experienced a slight stuffy nose in the early morning hours of monday, (b)(6).He and his wife boarded a flight to the pacific nw and he continued to increase in symptom severity.He tested + monday night, his wife negative.I tested monday as soon as i received the news, again tuesday and called my physician as i am in a high risk category for multiple factors (chronic respiratory problems, age > 64, poor fitness due to prior covid in (b)(6)2023).I saw him on wednesday (b)(6) 2023 and started paxlovid on the clinical assumption that i was positive.Pcr-naat results this am: +.On the box label, "if you have symptoms of covid you can use a single test" and "do use as an aid in the diagnosis of covid-19 and if you are concerned that you have been exposed to covid-19." i tested on monday, tuesday, and today after receiving the lab results: all three times the test was definitively negative (ie.Only a solid c bar and no trace on the t bar) in exactly the same way.I am a physiologist and health care provider so am convinced i performed the test exactly as directed.My symptoms are much worse today even though i started the paxlovid last night.My peak expiratory flow rate is 200liters/ min (normal values for my age are 378-30 liters/min; br medical j.1989:289; 1068-1070) and hr(heart rate) up to 120 and sob(shortness of breath) with minimal exertion.Why would the (b)(6) make self tests available to its staff and use as judgment for return to work following covid in the presence of so many false negatives?: my friend and her colleagues all tested with the home tests supplied by mayo and all were negative and all were doing what they thought was prudent based on the information they had.Doesn't this put already-ill patients at risk? ihealth labs inc.Made in china.Covid-19 screening test performed on (b)(6) 2023.Ref reports: mw5145015, mw5145017.

• 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, ; CH
• MDR Report Key: 17892574
• MDR Text Key: 325700773
• Report Number: 3008573045-2023-00041
• 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: 10/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/14/2023
• Device Model Number: ICO-3000
• Device Lot Number: 221CO20815
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: MW5145015
• Patient Sequence Number: 1
• Patient Age: 65 YR