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

Model Number STRIP, CVS KETONE 50CTDIET

Device Problem No Device Output (1435)

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

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.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 negative/no change trace results of the ketone test strips.Customer stated that the color does not change when he tests.The test strip lot manufacturer¿s expiration date is 02/21/2023 and customer stated he had purchased the test strips three days ago.The package had not been open or damaged when received by the customer.The product is not stored according to specification (kitchen).The customer is using the ketone test strips for a keto diet.Customer stated that he had no solid food for the past few days.The customer feels well and did not report any symptoms.Offered to replace the strips but customer states that he will continue to use them and see if they change and then call us back.

Manufacturer Narrative

Sections with additional information as of 01-dec-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-061: improper use/mishandle by end user.

• 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: 12732970
• MDR Text Key: 281029529
• Report Number: 1000113657-2021-00689
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

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: 02/21/2023
• Device Model Number: STRIP, CVS KETONE 50CTDIET
• Device Lot Number: AY624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/05/2021
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 11/01/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 12/01/2021
• 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