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

Model Number ICO-3000

Device Problems False Positive Result (1227); No Apparent Adverse Event (3189)

Patient Problem Anxiety (2328)

Event Date 02/19/2022

Event Type  malfunction  

Manufacturer Narrative

Review the production process inspection data and shipping inspection data of the sold products, and the inspection results are in line with the shipping guidelines.Ihealth covid-19 antigen rapid test intended use: it is suitable for a single measurement within the first 7 days of the onset of symptoms for people suspected of novel coronavirus.It is also suitable for screening of people without suspected symptoms but suspected of new coronavirus infection or suspected of new coronavirus infection for other epidemiological reasons.Screening can be performed twice within three days, with an interval of 24 to 48 hours.This product cannot be used alone for the diagnosis of new coronavirus infection, and the infection status should be judged in combination with other diagnostic information such as nucleic acid detection and imaging, as well as medical history and contact history.A positive result only indicates the presence of the novel coronavirus n antigen in the sample, and clinical correlation with past medical history and other diagnostic information is required to determine the infection status.A positive result does not rule out bacterial infection or co-infection with other viruses.A negative result does not rule out novel coronavirus infection and should not be used as the basis for individual treatment or management decisions (including infection control decisions).Based on the detection principle and relevant clinical data, the test results of the ihealth covid-19 antigen rapid test are directly related to the viral load in the sample.When the viral load in the sample is lower than the product's lowest limit of detection (lod), negative results may occur.The samples with lower viral load may be due to the low viral load at the sampling site of the user (the user is asymptomatic or mildly symptomatic), or it may be caused by improper sample collection due to improper operation.It is recommended to judge by continuous detection.Considering that the viral load of users may be different under different disease courses, the results measured by our test kit should be compared with the results of pcr at the same time.For example, some users responded that the results measured by our company's test kit were inconsistent with the pcr results that differed by more than one day.In this case, it may be that the user's own virus infection and virus volume have changed, which cannot be fully proved.The kit results are inaccurate.

Event Description

Customer feedback: this test gave us 6 false positives.We went to a clinic after and we never had covid.The clinic couldn't find traces of antibodies.Was a waste of money and time, because we couldn't go back to work and school thinking we had covid based on this test false results.Dont waste your money.

• 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: 13719976
• MDR Text Key: 296970214
• Report Number: 3008573045-2022-00127
• 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: 02/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• 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: 03/10/2022
• 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
• Patient Sequence Number: 1