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

Model Number STRIP, CVS KETONE 50CT

Device Problems Material Discolored (1170); No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Additional report reference number: (b)(4) - initial customer call.Ketone test strips were returned, no defect found.Most likely underlying root cause : mlc-061: improper use/mishandle by end user note: manufacturer contacted customer in a follow-up call on 10-feb-2021 to ensure the replacement product resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.Customer also stated she was diagnosed with stage 2 hepatitis c and believed the issue with her liver to be possible cause of issue with the product.

Event Description

Consumer reported complaint for ketone test strips stating that negative/no change trace results on test strips.While on the follow up call from the initial complaint, the customer stated the ketone test strips did not change color and same thing happening with the replacement product.The customer feels well and did not report any symptoms; medical attention is not reported associated with the use of the product.The package was not open or damaged when received and there was no evidence of the product being used previously.Customer was using the proper testing techniques.The customer declined to perform a test during the call.

Manufacturer Narrative

Sections with additional information as of (b)(6) 2021: h6: included fda's type of investigation, investigation findings, and investigation conclusions for additional 2 vials of ketone test strips.H10: additional 2 vials of ketone test strips were returned for evaluation.Product testing performed and no defect found most likely underline root cause: mlc-061: improper use/mishandle by end user.

• Brand Name: KETONE TEST STRIPS
• Type of Device: NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 11381091
• MDR Text Key: 239767346
• Report Number: 1000113657-2021-00145
• Device Sequence Number: 1
• Product Code: JIN
• UDI-Device Identifier: 021292008178
• UDI-Public: (01)021292008178
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

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: 07/17/2022
• Device Model Number: STRIP, CVS KETONE 50CT
• Device Lot Number: AX600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Distributor Facility Aware Date: 02/03/2021
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1