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

Model Number ICO-3000

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 06/10/2022

Event Type  malfunction  

Manufacturer Narrative

The customer does not provide specific product information or pictures.According to the customer description, there may be two situations: 1.The swab has blood stains before use.Swab is a packaging operation carried out in a purified environment, and there is no possibility of blood stains.Since there is no specific product information or pictures, an effective investigation cannot be carried out, and it is necessary to follow up whether customers provide new information.In the production process of the product, no such phenomenon has been found, but it cannot be ruled out that individual raw materials are defective.2.Blood stains appear after sampling with swab.There are clear requirements in the instructions:do not use on anyone who is prone to nosebleeds or has had facial or head.In view of the existence of blood stains after sampling, the verification result: endogenous interfering substances /whole blood(4% ):no cross-reactivity and no interference.

Event Description

Customer feedback: blood on swab mentioned, blood was there before swab.

• 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: 14926974
• MDR Text Key: 295318954
• Report Number: 3008573045-2022-00165
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00208563205894
• UDI-Public: 208563205894
• 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: 07/06/2022

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 Model Number: ICO-3000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2022
• Initial Date FDA Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR