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

Model Number STRIP, WALGREENS 100CTKETONE #383239

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Note: manufacturer contacted customer in three follow-up emails to obtain additional information and be able to support with the initial concern, unable to establish contact with customer at this time.

Event Description

Complaint received via email.Consumer reported complaint for negative/no change trace results of ketone test strips.Customer stated purchased two bottles of the ketone test strips and all her family (husband, children and her) have all used them and the ketone test strips did not change color when testing.The customer stated the ketone test strips had been a cream color when the package had first been opened.The package had not been open or damaged when received by the customer.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.The product is not stored according to specification (stored in the bathroom).The ketone test strip open vial date was two weeks prior to call.

Manufacturer Narrative

Sections with additional information as of 18-mar-2021: h6: updated fda¿s type, findings and conclusions codes.H10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested and passed.Most likely underlying 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: 11301145
• MDR Text Key: 246549237
• Report Number: 1000113657-2021-00091
• 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: 03/18/2021

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: 09/30/2021
• Device Model Number: STRIP, WALGREENS 100CTKETONE #383239
• Device Lot Number: AX578
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/13/2021
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1