MAUDE Adverse Event Report: IHEALTH / ANDON MEDICAL CO., LTD. IHEALTH COVID 19 ANTIGEN RAPID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number 20856362005894

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 06/19/2022

Event Type  malfunction  

Event Description

I used a ihealth antigen rapid at home test kit and the labelling on the product box is different from the label on the vial with respect to expiry date and lot# the box states that is lot (10): 211co21124 and to use by (17) 2022-05-23 while the vial is labelled with lot number cvd2121121 with a use by date of 2023-11-16.Please have them check their manufacturing procedures to implement corrective action.In our case the vials/actual product actually expired later though the lot number are different too.And the fda website posts some extended expiry information which introduces yet another expiry date.It says that for vials with a 2022-05-23, expiry date: 2022-05-23 = 2022-08-22.Fda safety report id # (b)(4).

• Brand Name: IHEALTH COVID 19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH / ANDON MEDICAL CO., LTD.
• MDR Report Key: 14787168
• MDR Text Key: 294670509
• Report Number: MW5110438
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/23/2022
• Device Model Number: 20856362005894
• Device Lot Number: 211CO21124
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2022
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White