MAUDE Adverse Event Report: TOP NOTCH NUTRITION LLC KETONE TEST STRIPS; NITROPRUSSIDE, KETONES (URINARY NON-QUANT)

Model Number ASIN:B075ZMQZQY

Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2018

Event Type  malfunction  

Event Description

I was trying to use top notch nutrition ketone test strips (company name is top notch nutrition), bought from (b)(6) (asin:(b)(4)) (upc: (b)(4)), and noticed the quality was not only horrible, but it registered a color of gray on the test pad, which is not even on the bottle's color chart.The product was defective upon unsealing it.Upon doing some research, it appears this product is manufactured in (b)(6) and travels all the way to the usa to be sold on (b)(6).My concern is that top notch nutrition: is selling this ketone test strip as an otc product without a u.S.Fda 510(k) clearance, i search the fda website and could not find their 510(k) clearance; is not listed on the fda website as a private labeler of this product (or any of their products for that matter); does not have a registered udi number with the u.S fda for this product or any products sold on (b)(6).I am asking you to verify this info about top notch nutrition not having an otc authorization with a u.S.Fda 510(k) clearance to sell this product on (b)(6).My concern is that (b)(6) mfrs can and do fabricate certifications, so if top notch nutrition does produce a 510(k) number, that you would do some due diligence and contact the president of that mfr of the 510(k) and verify they do, indeed, represent this company top notch nutrition with their 510(k).The quality of this product would indicate it does not have a 510(k).Additionally, i am requesting you verify that top notch nutrition has not registered with the fda as a private labeler or having a udi number - for this product, or any of their products under their brand name and company name of top notch nutrition.If this proves to be true, i do ask you take appropriate action against this company on (b)(6) ((b)(6) is listing and facilitating the sale of top notch nutrition ketone strips) and all other marketplaces.My concern is, given a consumer's diabetic condition, urine ketone values on this test strip might be misrepresented.I feel the consumer should know this is a cheap (b)(6)-made product being sold to unsuspecting consumers who might make medical decisions based on these top notch nutrition ketone test strips.Only use ketone test strips to monitor my diet and health.Thank you.

• Brand Name: KETONE TEST STRIPS
• Type of Device: NITROPRUSSIDE, KETONES (URINARY NON-QUANT)
• Manufacturer (Section D): TOP NOTCH NUTRITION LLC
• MDR Report Key: 8119702
• MDR Text Key: 129754665
• Report Number: MW5081746
• Device Sequence Number: 1
• Product Code: JIN
• 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: 11/28/2018

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 Operator: Lay User/Patient
• Device Expiration Date: 11/24/2019
• Device Model Number: ASIN:B075ZMQZQY
• Device Catalogue Number: ASIN:B075ZMQZQY
• Device Lot Number: 2017112404
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 93