MAUDE Adverse Event Report: SHIPFUSION C/O PERFECT KETO PERFECT KETO KETONE TEST STRIPS; NITROPRUSSIDE KETONES (URINARY NON-QUANT.)

Model Number ASIN: B01MUB7BU

Device Problems Material Discolored (1170); Defective Device (2588)

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

Event Date 11/17/2018

Event Type  malfunction  

Event Description

I was using perfect keto ketone test strips (company name is: (b)(6)), bought from (b)(6) (asin: (b)(4)) (upc: (b)(4)), and noticed they turned gray shortly after unsealing the bottle.The product was defective almost immediately.Upon doing just a little bit of research, it seems this product travels all the way from (b)(6) and sold on (b)(6).Don't they need a u.S.Fda 510(k) clearance to sell this product to consumers in the usa? their listing on (b)(6) says they are ¿100% lab grade,¿ and ¿doctor -formulated,¿ as well as ¿doctor developed.¿ but, how does a consumer know if, indeed, fda actually approves this company to sell this strip in usa? i have concerns about the efficacy of this product, especially all the way from (b)(6), over 10,000 miles away, via (b)(6), to arrive at my front door.Is it possible for you to look into this company to make sure they indeed have the proper clearance (510k) to sell this product to consumers on (b)(6)? thank you.

• Brand Name: PERFECT KETO KETONE TEST STRIPS
• Type of Device: NITROPRUSSIDE KETONES (URINARY NON-QUANT.)
• Manufacturer (Section D): SHIPFUSION C/O PERFECT KETO
• MDR Report Key: 8089825
• MDR Text Key: 128722843
• Report Number: MW5081478
• 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: 11/17/2018

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: 10/11/2019
• Device Model Number: ASIN: B01MUB7BU
• Device Catalogue Number: UPC: 755899993338
• Device Lot Number: 2017101001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2018
• 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