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

Model Number STRIP, CVS 100CT KETONE

Device Problem Unsealed Device Packaging (1444)

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

Event Date 03/28/2022

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were returned - product evaluation in-process.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for the ketone test strips.Customer stated he had purchased 100 count (two vials) of the ketone test strips on (b)(6) 2022 and that the lid on one of the vials had been open.Customer stated the second vial had been sealed and closed.Customer stated he had used one of the test strips to perform a test on (b)(6) 2022.Customer stated he was not concerned with the result obtained and did not recall what the result was.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 01-june-2022: h3: device evaluated by manufacturer.H6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: returned product was forwarded to packaging based on complaint's description.Internal evaluation has been completed, no abnormalities observed.Reported defect not reproduced on returned ketone strips.Product evaluation has been completed and most likely underlying root cause selected.Retention ketone strip lot tested within specifications, most likely underlying root cause: mlc-063: 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: 14187398
• MDR Text Key: 299074675
• Report Number: 1000113657-2022-00230
• 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
• Report Date: 06/01/2022

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: 06/26/2022
• Device Model Number: STRIP, CVS 100CT KETONE
• Device Lot Number: AX594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/28/2022
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 05/05/2022
• Supplement Dates FDA Received: 06/01/2022
• 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