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

Model Number	STRIP, CVS KETONE 50CTDIET
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Note: manufacturer made several attempts to contact customer to ensure the customer¿s initial concern was resolved- unable to establish contact with customer.
Event or Problem Description
Consumer reported complaint for negative/no change trace results of the ketone test strips.Customer stated that the color does not change when he tests.The test strip lot manufacturer¿s expiration date is 02/21/2023 and customer stated he had purchased the test strips three days ago.The package had not been open or damaged when received by the customer.The product is not stored according to specification (kitchen).The customer is using the ketone test strips for a keto diet.Customer stated that he had no solid food for the past few days.The customer feels well and did not report any symptoms.Offered to replace the strips but customer states that he will continue to use them and see if they change and then call us back.
Additional Manufacturer Narrative
Sections with additional information as of 01-dec-2021: h6: updated fda¿s type, findings and conclusions codes.H10: ketone test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-061: improper use/mishandle by end user.

• 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: 12732970
• Report Number: 1000113657-2021-00689
• Device Sequence Number: 19921575
• 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): 12/01/2021

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, CVS KETONE 50CTDIET
• Device Lot Number: AY624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 12/01/2021
• 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