MAUDE Adverse Event Report: TRIVIDIA HEALTH INC KETONE TEST STRIPS; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number STRIP, WALGREENSKETONE 50CT #496636

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone strips vial was not returned for evaluation.Customer discarded ketone strips vial.Most likely underlying root cause: mlc-61: improper use / mishandled by end user.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.

Event Description

Consumer reported complaint for no change trace results on ketone strips.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product storage location is undisclosed.During the call, a ketone test was performed by the customer and produced no response.The test strip lot manufacturer¿s expiration date is 10/20/2020 and open vial date is undisclosed.

Manufacturer Narrative

Sections with additional information as of 19-feb-2020: h10: retention testing was performed using test strips from the same lot.Retention strip lot tested and passed.

• Brand Name: KETONE TEST STRIPS
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 9495163
• MDR Text Key: 219778562
• Report Number: 1000113657-2019-10239
• 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: 02/20/2020

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: 10/20/2020
• Device Model Number: STRIP, WALGREENSKETONE 50CT #496636
• Device Lot Number: AW476
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/21/2019
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1