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

Model Number STRIP, KETONE 50CT

Device Problem Unexpected Color (4055)

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

Event Date 10/02/2022

Event Type  malfunction  

Event Description

Consumer reported complaint for the ketone test strips.Complaint was reported via e-mail.Customer's e-mail stated that the ketone test strips "don¿t work at all" and that "the color just turns muddy looking and does not come close to anything on the color chart." no symptoms and no medical intervention related to the use of the product was reported.Customer did not provide contact telephone number; email response had been sent to customer.

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Note: manufacturer contacted customer in follow-up e-mails to ensure the initial concern is resolved - unable to establish contact with customer at this time.

Manufacturer Narrative

Sections with additional information as of 22-nov-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10:ketone 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-020: user's test strip had poor storage.

• 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: 15666279
• MDR Text Key: 303239887
• Report Number: 1000113657-2022-00569
• 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: 11/22/2022

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: 12/19/2023
• Device Model Number: STRIP, KETONE 50CT
• Device Lot Number: AA657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/02/2022
• Initial Date Manufacturer Received: 10/02/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 11/01/2022
• Supplement Dates FDA Received: 11/22/2022
• 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