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

Model Number STRIP, WALGREENS 100CT KETONE #383239

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned - customer returned incorrect test strips.Note: manufacturer contacted customer in a follow-up call on 3-feb-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated she is experiencing the same with the replacement strips (the strips will not change color).New case was issued internally and a test strips replacement were issued on the new record.

Event Description

Consumer reported complaint for ketone test strips indicating that the color would not change - negative/no change trace results.The customer did not report symptoms at time of call.Medical attention is not reported as a result.The product storage location is undisclosed.During the call a ketone test was not performed by the customer.Customer is not diabetic, just following ketone diet.The ketone test strip open vial date is 01/24/2021.

Manufacturer Narrative

Sections with additional information as of 26-mar-2021: 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 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: 11342564
• MDR Text Key: 243201081
• Report Number: 1000113657-2021-00122
• 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: 03/26/2021

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 100CT KETONE #383239
• Device Lot Number: AX563
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/25/2021
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 03/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1