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

Model Number STRIP, WALGREENS DIETKETONE 50CT #104335

Device Problem Insufficient Information (3190)

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

Event Date 04/21/2023

Event Type  malfunction  

Event Description

Consumer reported complaint for the ketone test strips.Complaint was reported via e-mail.Customer stated that she has been using the ketone test strips for the past eight months and "that 1/4 at least of them are duds." no symptoms or medical attention associated with the use of the product was reported.No additional information was provided.

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.Manufacturer contacted customer in several follow-up emails in attempt to obtain additional information and ensure that the initial concern is resolved - unable to establish contact with customer at this time.

Manufacturer Narrative

Sections with additional information as of 22-jun-2023: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: ketone test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.

• 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: 16938134
• MDR Text Key: 315280228
• Report Number: 1000113657-2023-00271
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

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 Expiration Date: 07/30/2024
• Device Model Number: STRIP, WALGREENS DIETKETONE 50CT #104335
• Device Lot Number: AA678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/21/2023
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/22/2023
• 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