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

Model Number ICO-3000

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

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

Event Date 09/16/2022

Event Type  malfunction  

Event Description

Customer feedback : this is with regards to the ihealth covid-19 antigen rapid test kit.These tests are purchased by ouramerican consumers to ensure that they are testing themselves and their loved ones, andappropriate quality devices should be in the market as these test kits can help prevent public healthissues.Approximately 200,000 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 70% 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 200,000 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 (b)(6) 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,(b)(6) 2022 to hudson scientific: 51, 51, lot 223co20122, 7121/2022, to hudson scientific; 45, 12, lot 221co20111-05, 7/10/2022, to hudson scientific: 45, 45, lot 223c020122, 7121/2022, 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 nonconforming.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 errori liability/nonconformance kindly find my lot numbers and expiry dates as purchased from ihealth labs, usa: "lot #: expiry 211c021215, 6/14 223c020122, 7121 223c020122, 7121 221c020107, 7/6 221c020107,716221co20107, 716 221c021215, 6/14 223c020122, 7121 221co20121, 7/20 223c020122, 7121 221c021215, 6/14 221co20121, 7/20.

Manufacturer Narrative

Ihealth labs conducted the inspection of the products of m4 on (b)(6).Inspected all the products in the warehouse, 12 pallets in total.And among them, 9 pallets are counterfeit products.A new lot 221co20111-05 was found in the inspection.M4's lot numbers lot #: 221co21215: 3 pallets = 45,360 total tests (counterfeit) , lot #: 221co20107: 2 pallets = 30,240total tests (counterfeit), lot #: 221co20121: 3 pallets = 43,020 total tests ((genuine), lot #: 223co20122: 4 pallets = 60,480 total tests (counterfeit), lot #: 221co20111-05: 13 cartons= 2340 total tests (genuine).For the two genuine lots, we also inspect the reported "no liquid in the tube or less liquid in the tube" claim.500 tests were sampled from lot 221co20121, and 26 tests were sampled from lot 221co20111-05.And the results are within the acceptable range.The owner of m4, shilpi biswas agreed with the inspection result and agreed m4 will not sell the counterfeit devices in the market.We also reported this case to the fda criminal office.

• 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: 15657514
• MDR Text Key: 307155693
• Report Number: 3008573045-2022-00198
• 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: 10/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/01/2023
• Device Model Number: ICO-3000
• Device Lot Number: 221C020107
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: MW5112183
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 50 YR
• Patient Sex: Male