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

Model Number	STRIP, CVS 100CT KETONE
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 1000113657-2021-00720
• Device Sequence Number: 11210608
• Product Code: JIN
• UDI-Device Identifier: 00021292008178
• UDI-Public: 021292008178
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown