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

Model Number 20856362005894

Device Problems Product Quality Problem (1506); Defective Component (2292)

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

Event Date 07/06/2022

Event Type  malfunction  

Event Description

This is with regards to the ihealth covid-19 antigen rapid test kit.These tests are purchased by our american consumers to ensure that they are testing themselves and their loved ones, and appropriate quality devices should be in the market as these test kits can help prevent public health issues.Approximately (b)(4) of these kits were in my possession with expiry date of july 2022.Attached letter from fda, signed by dr.(b)(6) (director microbiology) has granted these test kits an additional shelf life of 12 months (so the expiry of my lots now is july 2023).My lots were sold to a school on (b)(6) 2022.However, the school immediately discovered that the solution in the vials were either nonexistent or down to barely a drop.Without solution in the vials, these rapid antigen tests are "faulty", and fall into the device malfunction category.The school returned the purchase back to me.I hired a third-party inspection agency (b)(4) who inspected and found about (b)(4) failures in these lots (solution missing).I then hired a former fda officer who runs his inspection and lab agency (b)(4) and their inspector has found 73% missing solutions in the samples as taken from my (b)(4) ihealth tests.Ihealth (mr.(b)(6) ceo) was sent the full inspection and validation report along with a letter from me and my litigation firm on aug 10, 2022.As of sep 19, 2022, there has been no acknowledgement of the letter or the inspection report from ihealth labs ceo's office or ihealth labs policy/quality department.Sample data pallet# sampled, failures type, expy, shipping data: 39 39, lot 223co20122, 7/21/2022 to hudson scientific; 51, 51, lot 223co20122, 7/21/2022, to hudson scientific; 45, 12, lot 221co20111-05, 7/10/2022, to hudson scientific; 45, 45, lot 223co20122, 7/21/2022, to hudson scientific; 45, 4, lot 221co20121, 7/20/2022, to hudson scientific; 45, 28, lot 211co21215, comments to m4 safety soln; 60, 60, lot 221co20101, comments to m4 safety soln.Totals 375, 284, % failure 75.73.The eua granted to ihealth labs is: (b)(4).My ardent request is that fda which is granting eua to these device manufacturers to test american citizens to avoid public pandemic, ensure that the ihealth labs manufacturer is keeping their end of the requirements.They need to report out lots which have been problematic and non-conforming.The non conformance can stem from various issues, and quality control processes are core for any medical item.Please ensure that ihealth is held accountable for this major error/liability/nonconformance.Kindly find my lot numbers and expiry dates as purchased from ihealth labs, usa: "lot #: expiry 211co21215, 6/14 223co20122, 7/21 223co20122, 7/21 221co20107, 7/6 221co20107, 7/6 221co20107, 7/6 221c021215, 6/14 223co20122, 7/21 221co20121, 7/20 223co20122, 7/21 221c021215, 6/14 221co20121, 7/20 221co20121 7/20." 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 LABS, INC.
• MDR Report Key: 15462374
• MDR Text Key: 300708502
• Report Number: MW5112183
• Device Sequence Number: 5
• 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: 09/19/2022
• 13 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 20856362005894
• Device Lot Number: 223CO20122
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian