MAUDE Adverse Event Report: IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 221CO20214

Device Problem Short Fill (1575)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2022

Event Type  malfunction  

Event Description

My husband and i received 8 boxes of covid tests from (b)(6).Lot# 221co20214.I have opened 3 of the boxes to attempt tests but none of them are usable because there isn't enough fluid in the ampules to fill the vials to the required fill line.The ampules are obviously under-filled and in differing amounts.Sometimes it is a bit short and in one box, one ampule didn't even fill the vial to half of the required fill line.These things are dangerous and have been sent to many seniors who might not notice that the ampule is not filling the vial in the correct amount.(b)(4).

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC.; 150c charcot ave; san jose CA 95131
• MDR Report Key: 15275838
• MDR Text Key: 298491608
• Report Number: MW5111630
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 5636200589
• UDI-Public: 5636200589
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/18/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/13/2022
• Device Lot Number: 221CO20214
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White