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

Model Number STRIP, WALGREENS 100CTKETONE #383239

Device Problem No Device Output (1435)

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

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were returned - product evaluation in-process.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-001: user had an inaccurate reference.Note: manufacturer contacted customer in a follow-up call on 26-feb-2024 to ensure the customer¿s initial concern was resolved - able to establish contact with customer who stated the replacement products resolved initial concern.

Event Description

Consumer reported complaint for the trueplus ketone test strips.Mother is calling on behalf of the customer.Mother stated that the ketone strips not changing color when sample is applied.The package had not been open or damaged when received.The customer has been using the product for 2-3 months for diabetes management.The customer is storing and handling the test strips correctly.The customer feels well and did not report any symptoms and medical attention related to the use of the product was not reported.

Manufacturer Narrative

Sections with additional information as of 25-mar-2024: h3: was the device evaluated by the manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: ketone test strips were returned for evaluation.Product testing was performed and defect found on returned ketone test strips: physical defect of strips; discolored grey pads.Root cause: rc-072: vial left open for an extended period of time.

• 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: 18837474
• MDR Text Key: 337245522
• Report Number: 1000113657-2024-00098
• 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: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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 Model Number: STRIP, WALGREENS 100CTKETONE #383239
• Device Lot Number: AB682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/07/2024
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/25/2024
• 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