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

Model Number STRIP, CVS 100CT KETONE

Device Problem No Device Output (1435)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Retention testing was performed using ketone test strips from the same lot.Retention strips tested within specifications.Most likely underlying root cause: mlc-061: improper use/mishandled by end user.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2023 to ensure and to ensure the customer¿s initial concern was resolved- customer states she is no longer using the ketone strips and declined replacement.

Event Description

Consumer reported complaint for the ketone test strips.Customer stated that the ketone test strips are not changing color when she is running a urine sample.Customer is using the ketone test strips for diabetes management and not for dietary reasons.Customer stated that ketone test strips were the normal color of beige when first opened.During the call, a urine test was performed by the customer and test was negative for ketones.The test strip lot manufacturer¿s expiration date is 12/31/2024 and customer has been using the product for a few weeks.

• 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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 18650686
• MDR Text Key: 334781143
• Report Number: 1000113657-2024-00045
• Device Sequence Number: 1
• Product Code: JIN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/06/2024

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 Model Number: STRIP, CVS 100CT KETONE
• Device Lot Number: AB691
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/09/2024
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1