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

Model Number	STRIP, KETONE 50CT
Medical Device Problem Code	Unexpected Color (4055)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the ketone test strips.Complaint was reported via e-mail.Customer's e-mail stated that the ketone test strips "don¿t work at all" and that "the color just turns muddy looking and does not come close to anything on the color chart." no symptoms and no medical intervention related to the use of the product was reported.Customer did not provide contact telephone number; email response had been sent to customer.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Note: manufacturer contacted customer in follow-up e-mails to ensure the initial concern is resolved - unable to establish contact with customer at this time.
Additional Manufacturer Narrative
Sections with additional information as of 22-nov-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-020: user's test strip had poor storage.

• 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: 15666279
• Report Number: 1000113657-2022-00569
• Device Sequence Number: 2810005
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: 021292008178
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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: 12/19/2023
• Device Model Number: STRIP, KETONE 50CT
• Device Lot Number: AA657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/02/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 11/22/2022
• 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