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

Model Number	STRIP, WALGREENS 100CTKETONE #383239
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 21-oct-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.Customer stated that the ketone test strip vial had been open in the sealed box when received.Customer stated that the box did not appear to be tampered with.The customer stated he did not use any of the ketone test strips from the vial.The customer feels well and did not report any symptoms.No medical attention related to the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 04-jan-2022.H6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: ketone test strips were not returned for evaluation- testing of retention strip lot tested within specifications.Internal evaluation has been completed, and root cause selected.No abnormalities observed.Most likely underlying root cause: mlc-063: poor tech-other.Damaged during transit.
Additional Manufacturer Narrative
Sections with additional information as of 05-april-2022: d9: device available for evaluation.H3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: ketone strips were returned for evaluation.Defect found on returned strips: physical defect of strips; discolored grey pads.No further investigation required.Product evaluation has been completed and root cause selected.Root cause: rc-003: other root cause: damaged during transit.

• 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: 12759186
• Report Number: 1000113657-2021-00700
• Device Sequence Number: 6119764
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: 021292008178
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2022

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: 10/18/2022
• Device Model Number: STRIP, WALGREENS 100CTKETONE #383239
• Device Lot Number: AY610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/11/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 12/09/2021; 03/08/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 01/04/2022; 04/05/2022
• 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