MAUDE Adverse Event Report: UNKNOWN BIKENDA¿ NEXT-GENERATION INTELLIGENT MULTIFUNCTIONAL NON-INVASIVE LASER BLOOD GL; OXIMETER

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6), 2024, i saw an ad on facebook for the bikenda¿ next-generation intelligent multifunctional non-invasive laser blood glucose meter for (b)(6).However, i was charged (b)(6) with higher shipping charges than shown on the order.When the device arrived on (b)(6), 2025, it was not the product advertised.It was nothing more than a cheap knock-off of an oxygen/pulse meter.It did not perform any of the other functions advertised in the ad nor any of the functions listed on the package.The product was advertised as 'made in america,' but the item was shipped from china.The ad also claimed the product is 'fda approved' which i now doubt to be true.I have tried to email every address listed on their emails, but all have been returned as undeliverable because the address doesn't exist.I tried to dispute the charge with my credit card bank but was told i have to try to resolve my complaint with the seller first.The bank provided a phone number listed for the seller, but the number is non-working.I would like to see the fda put a stop to this company's fraudulent activity!!! (b)(6) (revolutize ltd).

• Brand Name: BIKENDA¿ NEXT-GENERATION INTELLIGENT MULTIFUNCTIONAL NON-INVASIVE LASER BLOOD GL
• Common Device Name: OXIMETER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 21114889
• Report Number: MW5164494
• Device Sequence Number: 7057088
• Product Code: DQA
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 01/06/2025

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MINERALS.; MULTIVITAMINS.; OMEPRAZOLE.
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White