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

Model Number STRIP, WALGREENS 100CTKETONE #383239

Device Problem No Device Output (1435)

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

Event Date 09/27/2021

Event Type  malfunction  

Event Description

Consumer reported complaint for the ketone test strips, stating the test strip did not change color when performing a test.Customer stated she purchased the ketone test strips that day; the test strip lot manufacturer¿s expiration date is 01/19/2022.Customer stated the vial had been sealed when purchased.No symptoms or medical attention associated with the use of the product was reported.Coordinator had initially spoken with customer and transferred customer's information to technician.Technician was unable to contact the customer via telephone, no further information was able to be obtained.

Manufacturer Narrative

(b)(4).Ketone test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 20-oct-2021 to ensure the customer¿s initial concern was resolved- able to establish contact with customer.Customer says she no longer needs assistance.Her issue is resolved.

Manufacturer Narrative

Sections with additional information as of 01-dec-2021: h6: updated fda¿s type, findings and conclusions codes.H10: ketone test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: (b)(4): user had an inaccurate reference.

• 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: 12685777
• MDR Text Key: 284320793
• Report Number: 1000113657-2021-00667
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

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: 01/19/2022
• Device Model Number: STRIP, WALGREENS 100CTKETONE #383239
• Device Lot Number: AX590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/27/2021
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 12/01/2021
• 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