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

Model Number STRIP, WALGREENS DIETKETONE 50CT #104335

Device Problems Contamination (1120); No Device Output (1435)

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

Event Date 09/23/2021

Event Type  malfunction  

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 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.

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
• 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: 12673052
• MDR Text Key: 280154711
• Report Number: 1000113657-2021-00663
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 12/07/2021
• 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