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

Model Number STRIP, WALGREENSKETONE 50CT #496636

Device Problem No Device Output (1435)

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

Event Date 06/13/2023

Event Type  malfunction  

Event Description

Consumer reported complaint of negative/ no change trace results for the trueplus ketone test strips.Customer stated that he has been using the ketone test strips for over a month and a half and the test strips have never changed in color; customer stated that he feels that the strips are not working.The package had not been open or damaged when received by the customer.The customer stated that the test strips were peach beige in color when the package was first opened.Customer stated he is using the ketone test strips for a keto diet, not for diabetes management.The customer is storing and handling the ketone test strips correctly.The customer is using proper testing techniques.The customer declined to perform a urine test during the call.The customer feels well and did not report any symptoms.No medical attention related to the use of the product was reported.

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Most likely underlying root cause: mlc-001: user had an inaccurate reference.Note 1: customer contacted manufacturer in a follow-up call on 19-jun-2023 to report that he had discarded the replacement product; customer was referred to pharmacy.Note 2: manufacturer contacted customer in a follow-up call to ensure to ensure the initial concern is resolved - unable to establish contact with customer at this time.

Manufacturer Narrative

Sections with additional information as of 08-aug-2023: 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.Note: manufacturer contacted customer in a follow-up call on 11-jul-2023 to ensure to ensure the initial concern is resolved - able to establish contact with customer who stated he had taken the product back to the pharmacy and was refunded.Customer had once more stated that he had accidentally discarded the replacement bottle of ketone test strips that were sent to him.The customer is no longer using the trueplus ketone test strips.

• 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: 17287284
• MDR Text Key: 318835210
• Report Number: 1000113657-2023-00367
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 021292008178
• UDI-Public: (01)021292008178
• Combination Product (y/n): N
• 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: 08/08/2023

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, WALGREENSKETONE 50CT #496636
• Device Lot Number: AB681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/13/2023
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 08/08/2023
• 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