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

Model Number	STRIP, WALGREENSKETONE 50CT #496636
Medical Device Problem Codes	Material Discolored (1170); No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Note: manufacturer made several attempts to contact customer to ensure the replacement products resolved the initial concern.Unable to establish contact with customer.
Event or Problem Description
Consumer reported complaint for the ketone test strips.Mother is calling on behalf of the customer, her (b)(6) son.Mother stated that the day prior she had opened a vial of the ketone test strips and the strips were "charcoal gray" in color.Mother stated the test strips won't change color when used to test.Mother stated that the package had not been open or damaged when received.The test strip lot manufacturer¿s expiration date is 08/14/2022.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.
Additional Manufacturer Narrative
Sections with additional information as of 15-feb-2022: d9: device available for evaluation.H3: device evaluated by 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: physical defect of strips, discolored grey pads.Root cause: rc-061: storage outside specifications.

• 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: 12987575
• Report Number: 1000113657-2021-00770
• Device Sequence Number: 1673796
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: 021292008178
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 02/15/2022

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: 08/14/2022
• Device Model Number: STRIP, WALGREENSKETONE 50CT #496636
• Device Lot Number: AX603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/17/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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