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

Model Number STRIP, WALGREENS 100CTKETONE #383239

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Date 01/21/2022

Event Type  malfunction  

Event Description

Consumer reported complaint for negative/ no change trace results for the ketone test strips.Customer stated that when performing a urine test the ketone test strips did not change color.Customer is using the ketone test strips for the keto diet.During the call, a urine test was performed by the customer and the test strips did not show negative / no change trace results.The customer feels well and did not report any symptoms.Customer states that she is not sure she should be expecting a color change.Customer states that she will try to use it again and will call us back if she have any questions no medical attention associated with the use of the product was reported.

Manufacturer Narrative

Internal report reference number: 103467-1.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.

Manufacturer Narrative

Sections with additional information as of 18-apr-2022: 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 passed within specifications.Most likely underlying root cause: mlc-001: user had an inaccurate reference.

• 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: 13546214
• MDR Text Key: 288482700
• Report Number: 1000113657-2022-00084
• 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: 04/18/2022

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: 08/16/2022
• Device Model Number: STRIP, WALGREENS 100CTKETONE #383239
• Device Lot Number: AX604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/21/2022
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 03/22/2022
• Supplement Dates FDA Received: 04/18/2022
• 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