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

Model Number STRIP, TVH KT 100CT

Device Problem Material Discolored (1170)

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

Event Date 05/22/2023

Event Type  malfunction  

Event Description

Consumer reported complaint for the trueplus ketone test strips.Customer stated he had purchased 100ct (two vials) of the ketone test strips and that the test strips in one of the vials are grey in color.Customer stated the test strips in the second vial are not discolored and are working as intended.The package had not been open or damaged when received by the customer.The customer is using the ketone test strips for a keto diet.The product is not stored according to specification (bathroom).The test strip lot manufacturer¿s expiration date is 06/27/2024 and customer has been using the product since (b)(6) 2023.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were returned for evaluation.Product testing was performed and defect found on returned ketone test strips: physical defect of strips; discolored grey pads.Root cause: rc-061: storage outside specifications.Note 1: manufacturer contacted customer in a follow-up call on 31-may-2023 to ensure the replacement product resolved the initial concern - able to establish contact with customer who stated he had received the replacement product but had not yet used it.Note 2: manufacturer contacted customer in several follow-up calls to ensure the replacement product resolved the initial concern - unable to establish contact with customer at this time.

Manufacturer Narrative

Sections with additional information as of 10-jul-2023: h6: updated fda¿s type, findings and conclusions codes.H10: retention testing was performed using ketone test strips from the same lot.Retention strip lot passed within specifications.

• 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: 17134533
• MDR Text Key: 317482080
• Report Number: 1000113657-2023-00326
• 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,Followup
• Report Date: 07/10/2023

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, TVH KT 100CT
• Device Lot Number: AA674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/22/2023
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 07/10/2023
• 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