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

Model Number STRIP, TVH KT 100CT

Device Problem Unsealed Device Packaging (1444)

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

Event Date 10/24/2022

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips (2 vials) were returned for evaluation.Product testing was performed and no defect found.Returned product was forwarded to packaging and internal evaluation completed.No abnormalities observed.Most likely underlying root cause: mlc-063: damaged during transit.Note: manufacturer contacted customer in a follow-up call on 07-nov-2022 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 had purchased 100 ct but stated only one of the vials had been opened.Customer stated the ketone test strips had been purchased from amazon and the box had been sealed.Customer stated she did not perform any tests using the test strips.The customer feels well and did not report any symptoms and medical attention related to the use of the product was not reported.

Manufacturer Narrative

Sections with additional information as of 08-dec-2022: h6: updated fda¿s type, findings and conclusions codes.H10: retention testing was performed using test strips from the same lot.Retention strip lot tested 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: 15824639
• MDR Text Key: 307693451
• Report Number: 1000113657-2022-00605
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 021292008178
• UDI-Public: (01)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: 12/08/2022

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Model Number: STRIP, TVH KT 100CT
• Device Lot Number: AA655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/24/2022
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 12/08/2022
• 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