MAUDE Adverse Event Report: TRIVIDIA HEALTH INC KETONE TEST STRIPS; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number STRIP, KETONE 50CT

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2019

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Most likely underlying root cause: mlc-20: user's test strip had poor storage.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.

Event Description

Consumer initially reported complaint via e-mail for physical defect of ketone test strips (discolored grey / color does not match chart on vial); customer was contacted via telephone.Customer stated she was obtaining a color that was not shown on the chart.Customer is using the ketone test strips for a keto diet and not for diabetes management.Customer stated she has been on and off the keto diet for over a year now.Customer stated this was first time she used the product out of the package.Customer stated the ketone strips were tan in color when the package was first opened.The package was not opened or damaged when received by the customer.The product is not stored according to specification and is stored in the bathroom.The ketone tests strips manufacturer's expiration date is 01/31/2021; customer stated that they were purchased a couple of months ago but were not opened until (b)(6) /2019.The customer feels well and did not report any symptoms.Medical attention was not required at an earlier time.

Manufacturer Narrative

Sections with additional information as of 28-feb-2020: h6: updated fda's method, result, and conclusion 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 and passed.

• Brand Name: KETONE TEST STRIPS
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 9616175
• MDR Text Key: 221009325
• Report Number: 1000113657-2020-00043
• Device Sequence Number: 1
• Product Code: JIN
• Combination Product (y/n): N
• PMA/PMN Number: K000000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

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: 01/31/2021
• Device Model Number: STRIP, KETONE 50CT
• Device Lot Number: AW498
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/30/2019
• Initial Date Manufacturer Received: 12/30/2019
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1