MAUDE Adverse Event Report: URS-14 URINALYSIS REAGENT STRIPS SOOMIO; METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)

Lot Number	AB2408-001
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Hello, i recently purchased a 14-panel urinalysis test strip product on amazon, sold under the brand name soomio.This product raised several red flags, and i feel it's important to share my experience for the sake of consumer safety.First, the product's packaging had no information about the manufacturer or any contact details.There was no company name, address, or even a way to reach out for support.For a medical product that people rely on for their health, this was extremely concerning.Even more alarming, when i used the test strips, they indicated high levels of glucose in my urine.As someone who needs to monitor my glucose levels closely, this result was terrifying.I immediately went to my doctor to confirm the results, only to find out that my glucose levels were perfectly normal.The test strips had given me a false reading, which caused a lot of unnecessary stress and concern.What worries me most is that this false result could have had serious consequences for my health if i hadn't double-checked it.I rely on accurate glucose readings, and making decisions based on these faulty test strips could have led to significant health issues.The combination of incorrect results and the lack of company information on the product is deeply troubling.As a consumer, i should be able to trust that the medical products i use are both safe and reliable.I'm hoping the fda can investigate this product to ensure it meets the necessary standards for accuracy and transparency, so that other families don't go through the same scare i did.Thank you for your attention to this matter.I'm happy to provide more information if needed.Sincerely, (b)(6).

• Brand Name: URS-14 URINALYSIS REAGENT STRIPS SOOMIO
• Common Device Name: METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
• MDR Report Key: 20212601
• Report Number: MW5159586
• Device Sequence Number: 14510072
• Product Code: JIL
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Lot Number: AB2408-001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Hispanic