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 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Information was provided to technician who was unable to contact school nurse via telephone; no further information was able to be obtained.Note: manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for negative/ no change trace results on the ketone test strips.School nurse is calling on behalf of the customer stating that after performing a test, the ketone test strips did not change color.School nurse stated that the ketone test strips are used for diabetes management, as the customer's blood sugar is higher than normal.The customer feels well and did not report any symptoms.No medical attention was reported.

Manufacturer Narrative

Sections with additional information as of 11-feb-2021: h6: updated fda's method, result, and conclusion 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-001: user had an inaccurate reference.

• 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: 11156855
• MDR Text Key: 230002478
• Report Number: 1000113657-2021-00023
• 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,health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

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: 08/31/2021
• Device Model Number: STRIP, WALGREENS 100CTKETONE #383239
• Device Lot Number: AX563
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/17/2020
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/12/2021
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1