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

Model Number STRIP, KETONE 50CT

Device Problem Material Discolored (1170)

Patient Problem Insufficient Information (4580)

Event Date 07/23/2021

Event Type  malfunction  

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 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.

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
• Type of Device: NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 12337791
• MDR Text Key: 268778485
• Report Number: 1000113657-2021-00492
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: 021292008178
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 10/05/2021
• Supplement Dates FDA Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1