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

Model Number STRIP, CVS 100CT KETONE

Device Problem Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(6).Ketone test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 20-jan-2020 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated the replacement product resolved the initial concern.

Event Description

Complaint received via email.Consumer reported complaint for physical defects of ketone test strips.Customer purchased a box of ketone strips and stated that no matter what try to do, the strips only reveal very faint colors.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored according to specification (bathroom).The test strip lot manufacturer¿s expiration date is 09/30/2021 and open vial date is (b)(6) 2021.

Manufacturer Narrative

Sections with additional information as of 15-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-020: user's test strip had poor storage.

• 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: 11286156
• MDR Text Key: 230546714
• Report Number: 1000113657-2021-00080
• 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: 03/15/2021

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, CVS 100CT KETONE
• Device Lot Number: AX574
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/11/2021
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1