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

Model Number ICO-3000

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Emotional Changes (1831); Headache (1880); High Blood Pressure/ Hypertension (1908); Urinary Frequency (2275); Arthralgia (2355)

Event Date 05/21/2022

Event Type  Injury  

Manufacturer Narrative

The customer did not leave contact information, did not provide medical records, and could not confirm whether the customer had a history of allergies, and could not effectively determine whether there was a direct connection between the abnormality of the body and the nasal swab.According to the customer's description, a pre-wet nasal swab was used to wipe the nostrils; according to the requirements for the use of nasal swabs in the instructions: use the nasal swab to wipe the nostrils first, and then immerse the wiped nasal swab in the eluent for elution.Customer used nasal swab the wrong way.Check the sterilization report of the batch of specimen collection swab used by the customer, and the test results are all qualified.Check the biocompatibility report of the batch of specimen collection swab used by the client, and the test results are all qualified.Continue to collect information: is there any new allergy symptoms in lot 211co21224.The after-sales service department continues to contact the customer to confirm whether the correct operation is performed according to the instructions.Check the covid-19 antigen rapid test instruction for use, the instructions for use of swab are valid and executable, and the instructions do not need to be improved.

Event Description

Customer feedback: concern of covid-19 exposure without symptoms prompted me to take the i-health at home self-test at around 7:30pm.I used the premoistened swab included in the kit, to swab my nasal cavity as described in the instructions.I went to bed about 10 pm.At around midnight, i was awoken by the following: the bottom of my feet were both hot and cold, i was restless, i felt pain in all of my joints which persists as i compose this report, i could not find a comfortable position to sleep, my blood pressure is elevated which is resulting in a persistent headache and remains elevated; i am experiencing frequent elimination.

• 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: 14787128
• MDR Text Key: 295060830
• Report Number: 3008573045-2022-00134
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 20856362005894
• UDI-Public: 20856362005894
• 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: 06/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/23/2022
• Device Model Number: ICO-3000
• Device Lot Number: 211CO21224
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: MW5109839
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Prefer Not To Disclose