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 Diabetic Ketoacidosis (2364)

Event Date 02/03/2023

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Adverse event report is being submitted due to customer contacting doctor.Ketone test strips were not returned for evaluation.Added most likely underlying root cause onto case as the complaint product was not returned for investigation.Most likely underlying root cause: mlc-001: user had an inaccurate reference note: manufacturer contacted customer in a follow-up call on 13-feb-2023 to ensure that the initial concern was resolved - able to establish contact with customer who stated that she did not understand the color obtained - customer stated she was getting a magenta color on the strips and a circle inside the square on the test strips.Customer stated she had been in ketosis and had gone to the doctor.The customer had been told to drink something to bring back her electrolytes that¿s what helped her and it brought her sugar low.Customer states that she ended up changing the test strips and got new ones.Customer stated she will not use the ketone test strips again and disconnected the call.

Event Description

Consumer reported complaint for the ketone test strips.The customer stated the test strip did not change color when she had tested; the strip had a circle with a light pink color and one strip had negative.The customer declined to provide her full name.The customer feels well and did not report any symptoms.Medical attention related to the use of the product was not reported.The ketone test strip lot manufacturer¿s expiration date is 03/31/2023 and open vial date is undisclosed.

Manufacturer Narrative

Sections with additional information as of 28-mar-2023: 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 ketone strip lot tested 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: 16464508
• MDR Text Key: 310492344
• Report Number: 1000113657-2023-00121
• Device Sequence Number: 1
• Product Code: JIN
• 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: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Model Number: STRIP, KETONE 50CT
• Device Lot Number: AY630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/03/2023
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 03/02/2023
• Supplement Dates FDA Received: 03/28/2023
• 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
• Patient Outcome(s): Other