MAUDE Adverse Event Report: JUST FITTER JUST FITTER KETONE TEST STRIPS; NITROPRUSSIDE, KETONES (URINARY, NON-QUANT)

Model Number ASIN: B01J9LOP4M

Device Problems Product Quality Problem (1506); Defective Device (2588)

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

Event Date 11/24/2018

Event Type  malfunction  

Event Description

I was trying to use the brand of just fitter ketone test strips (company name is also called just fitter), bought from (b)(6) (asin: (b)(4)) (upc: (b)(4)), and noticed the quality was not only questionable, 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 shortly after unsealing it.Upon doing some research, this product is manufactured in (b)(4) and travels all the way to the usa to be sold on (b)(6).My concern is that just fitter: is selling this ketone test strips as an otc product without a u.S.Fda 510(k) clearance; is not listed on fda website as a private a labeler of this products ( 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 information about just fitter 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)(4) manufacturers can and do fabricate certifications, so if just fitter does produce a 510(k) number, that you would do some due diligence and contact the president of that manufacturer of the 510(k) and verify they do, indeed, represent this company just fitter with their 510(k).The quality of this product would indicate it does not have 510(k).Additionally, i am requesting you verify that just fitter has not registered with the fda as a private labeler or having a udi number- for this products, or any of their products under their brand name and of just fitter.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 just fitter 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)(4)-made product being sold to unsuspecting consumers who might make medical decisions based on these just fitter ketone test strips.Thank you! (b)(4).

• Brand Name: JUST FITTER KETONE TEST STRIPS
• Type of Device: NITROPRUSSIDE, KETONES (URINARY, NON-QUANT)
• Manufacturer (Section D): JUST FITTER
• MDR Report Key: 8138725
• MDR Text Key: 130170162
• Report Number: MW5081887
• 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: 12/03/2018

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: 01/03/2020
• Device Model Number: ASIN: B01J9LOP4M
• Device Catalogue Number: ASIN: B01J9LOP4M
• Device Lot Number: 2017122903
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 93