MAUDE Adverse Event Report: TRIVIDIA HEALTH INC KETONE; NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)

Model Number	STRIP, WALGREENSKETONE 50CT #496636
Medical Device Problem Codes	Material Discolored (1170); No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the ketone test strips.The customer stated that the test strips were possibly grey in color when the package was first opened.Customer also stated that test strips were not changing color when testing.Customer is using the ketone test strips for a ketone diet.The test strip manufacturer's expiration date is 02/21/2023; open vial date is (b)(6) 2022.The test strips are not being stored according to specification (kitchen).The customer did not have another vial of ketone test strips that had been stored correctly.The customer feels well and did not report any symptoms and medical attention related to the use of the product was not reported.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern, unable to establish contact with customer at this time.
Additional Manufacturer Narrative
Sections with additional information as of 20-may-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: ketone strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications most likely underlying root cause : mlc-001- user had an inaccurate reference.

• Brand Name: KETONE
• Common Device Name: NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 14164325
• Report Number: 1000113657-2022-00224
• Device Sequence Number: 5812799
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: 021292008178
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/21/2023
• Device Model Number: STRIP, WALGREENSKETONE 50CT #496636
• Device Lot Number: AY624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/24/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown