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

Model Number STRIP, WALGREENS 100CTKETONE #383239

Device Problems Material Discolored (1170); No Device Output (1435)

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

Event Date 02/16/2023

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).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-061: storage outside specifications.Manufacturer contacted customer in a follow-up call on (b)(6) 2023 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.Customer stated that the test strips were grey in color and that they did not change color.The package had not been open or damaged when received by the customer.Product storage was not disclosed.The ketone test strip lot manufacturer¿s expiration date is 11/30/2023.This is the first time the customer is using the product out of this package.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.Customer declined to perform a test during the call.

Manufacturer Narrative

Sections with additional information as of 04-apr-2023: h6: updated fda¿s type, findings and conclusions codes.H10: retention testing was performed using ketone test strips from the same lot.Retention strip lot passed within 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: 16528935
• MDR Text Key: 311154830
• Report Number: 1000113657-2023-00142
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 0212920081
• UDI-Public: (01)0212920081
• 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: 04/04/2023

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: 11/30/2023
• Device Model Number: STRIP, WALGREENS 100CTKETONE #383239
• Device Lot Number: AA655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/16/2023
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 03/13/2023
• Supplement Dates FDA Received: 04/04/2023
• 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