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

Model Number	STRIP, WALGREENS DIETKETONE 50CT #104335
Medical Device Problem Codes	Contamination (1120); No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Ketone test strips were returned for evaluation.Evaluation in process.Note: manufacturer contacted customer in a follow-up call on 28-sep-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Event or Problem Description
Consumer reported complaint for the ketone test strips.Sister is calling on behalf of the customer.Customer stated the ketone test strips are pale and not turning color.Explained to customer that the color on the pad is almost peach in color as shown on the color grid on the vial and not exactly white.Explained to customer that no color change means no ketones present.Referred customer back to her doctor to review diet expectations.Customer stated she is supposed to document her ketone amount daily.The package had not been open or damaged when received by the customer.This was the first time customer used the product out of this package.Customer stated that the test strip pads are not all white and appeared used.During the call a urine test was not performed by the customer.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 07-dec-2021: 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 no defect found.Most likely underlying root cause: mlc-001: user had an inaccurate reference.

• Brand Name: KETONE
• Common Device Name: 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: 12673052
• Report Number: 1000113657-2021-00663
• Device Sequence Number: 4775042
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: 021292008178
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/13/2023
• Device Model Number: STRIP, WALGREENS DIETKETONE 50CT #104335
• Device Lot Number: AY619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/23/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown