MAUDE Adverse Event Report: ONE EARTH HEALTH KETONE TEST STRIPS; NITROPRUSSIDE, KETONES (URINARY - NON-QUANT)

Model Number X000QGV60H

Device Problems Material Discolored (1170); 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 one earth health ketone test strips (company name is called lost leaf llc), bought from (b)(6) (asin: (b)(4)) (upc (b)(4)), and noticed the quality was not only questionable, but it registered a color of peach on the test pad, which is not even on the bottle's color chart.The product was defective.Upon doing some research, this product seems to be manufactured in (b)(4) (although the packaging suggests it is made in the usa, but i could not verify this) and travels all the way to the usa to be sold on (b)(6).My concern is that lost leaf llc: is selling this ketone test strip as an otc product without a u.S.Fda 510(k) clearance.I research the fda website and could not find their 510(k) clearance; is not listed on the fda website as a relabeler 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 not sure this product needs a udi number, but still, i could not find one still the same.I am asking you to verify this info about lost leaf llc not having an otc authorization with a u.S.Fda 510(k) clearance to sell this product on (b)(6).The quality of this product would indicate it does not have a 510(k).Additionally, i am requesting you verify that lost leaf llc has not registered with the fda as a private relabeler or having a udi number (if need to be) - for this product or any of their products under their brand name one earth health and company name of lost leaf llc.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 one earth health 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 one earth health ketone test strips.Thank you.(b)(6).This complaint is for the 150ct package of (asin: (b)(4)) (upc: (b)(4)).But, i see they have the exact same product in a 100ct package (asin: (b)(4)) (upc: (b)(4)) (b)(6).The unit ketones with one earth health ketone test strips were grossly inaccurate (b)(6) 2018.Lost leaf llc.

• Brand Name: ONE EARTH HEALTH KETONE TEST STRIPS
• Type of Device: NITROPRUSSIDE, KETONES (URINARY - NON-QUANT)
• MDR Report Key: 8142527
• MDR Text Key: 130079191
• Report Number: MW5081957
• 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: 12/04/2018
• 2 Devices were Involved in the Event: 1 2

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: 04/30/2019
• Device Model Number: X000QGV60H
• Device Catalogue Number: ASIN: B01MCU8NJ6
• Device Lot Number: 70282
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2018
• 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