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

Model Number STRIP, WALGREENS 100CTKETONE #383239

Device Problem Unsealed Device Packaging (1444)

Patient Problem Insufficient Information (4580)

Event Date 10/11/2021

Event Type  malfunction  

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 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.

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.

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
• 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: 12759186
• MDR Text Key: 285751426
• Report Number: 1000113657-2021-00700
• 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: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 12/09/2021; 03/08/2022
• Supplement Dates FDA Received: 01/04/2022; 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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