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

Model Number	STRIP, KETONE 50CT
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Note: customer contacted manufacturer via e-mail and provided telephone number.Manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for the ketone test strips; complaint was reported via e-mail.Customer stated they had recently purchased the true plus ketone test strips (within the last three weeks).Customer stated the test strips do not function as intended, and that they were a different color (tan) then other true plus ketone test strips they had.E-mail response was sent to customer requesting customer provide telephone number.
Additional Manufacturer Narrative
Sections with additional information as of 29-oct-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-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
• MDR Report Key: 12337791
• Report Number: 1000113657-2021-00492
• Device Sequence Number: 3974223
• 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): 10/29/2021

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: 12/31/2021
• Device Model Number: STRIP, KETONE 50CT
• Device Lot Number: AX589
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/23/2021
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1