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 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-061: improper use/mishandled by end user.Note: manufacturer made several attempts to contact customer to ensure the customer¿s initial concern was resolved- unable to establish contact with customer.

Event Description

Consumer reported complaint for the trueplus ketone test strips.Customer stated that the ketone test strips are not changing color.Customer stated he already try multiple times with no results.The package had not been open or damaged when received.The customer has been using the product for a keto diet for 1 week.The customer feels well and did not report any symptoms and medical attention related to the use of the product was not reported.The product is stored according to specification in the medicine cabinet.The test strip lot manufacturer¿s expiration date is 05/25/2025 and open vial date is 1 week ago.

• 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: 18967802
• MDR Text Key: 338681257
• Report Number: 1000113657-2024-00125
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 021292008178
• UDI-Public: (01)021292008178
• 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: Replace
• Type of Report: Initial
• Report Date: 03/25/2024

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: AB700
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/28/2024
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/25/2024
• 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