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

Model Number STRIP, CVS 100CT KETONE

Device Problem Unexpected Color (4055)

Patient Problem Insufficient Information (4580)

Event Date 11/22/2022

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Adverse event report is being submitted due to customer contacting doctor due to ketone test strips color not matching chart on the vial.Ketone test strips were returned - product evaluation in-process.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for the trueplus ketone test strips.Customer stated that the color does not match the chart on the vial.Customer stated that the color was dark (not purple), and that the dark color is not on the chart.The package had not been open or damaged when received by the customer.Customer has been using the ketone test strips for a year.The test strip lot manufacturer¿s expiration date is 06/30/2023 and the product is stored in the medicine cabinet.The customer is using the ketone test strips for diabetes management and for a keto diet.The customer feels well and did not report any symptoms.Customer stated she had contacted her doctor two weeks ago due to the color not matching the chart on the vial; customer stated the doctor had advised her to contact the manufacturer.

Manufacturer Narrative

Sections with additional information as of 11-jan-2023: h3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: defect found on returned strips: physical defect of strips; discolored grey pads.No further investigation required.Product evaluation has been completed and root cause selected.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications.Root cause: rc-061: storage outside specifications.

• 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: 15986894
• MDR Text Key: 308541493
• Report Number: 1000113657-2022-00658
• 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: Replace
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

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: 06/30/2023
• Device Model Number: STRIP, CVS 100CT KETONE
• Device Lot Number: AY638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/22/2022
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 12/15/2022
• Supplement Dates FDA Received: 01/11/2023
• 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