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

Model Number STRIP, CVS 100CT KETONE

Device Problem Material Discolored (1170)

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

Event Date 10/21/2021

Event Type  malfunction  

Event Description

Consumer reported complaint for the ketone test strips.Customer stated she had purchased 100 count (two vials) of the ketone test strips and that the padding on the test strips in one of the vials was grey in color.Customer did not report any concern with the ketone test strips from the other vial, and stated that they were the correct color.The package had not been open or damaged when received by the customer.This the first time the customer is using the product out of this package.Customer is using the ketone test strips for dietary purposes.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.Customer declined to perform a test during the call.

Manufacturer Narrative

(b)(4).Ketone test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 02-nov-2021 to ensure the replacement product resolved the initial concern - able to establish contact with customer who stated she had received the replacement product.Customer stated that she had not yet tested using the ketone test strips and would follow-up if further assistance was needed.

Manufacturer Narrative

Sections with additional information as of 04-jan-2022: 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: mlc-061: improper use/mishandle by end user.

• 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: 12819128
• MDR Text Key: 286247891
• Report Number: 1000113657-2021-00720
• 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: 01/04/2022

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: 12/27/2022
• Device Model Number: STRIP, CVS 100CT KETONE
• Device Lot Number: AY615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/21/2021
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 01/04/2022
• 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