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 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were returned product evaluation in-process.Most likely underlying root cause still pending of investigation completion.Note: manufacturer contacted customer in a follow-up email to ensure the replacement products resolved the initial concern able to establish contact with customer who stated that received container and ketone test strips work.

Event Description

Consumer reported complaint for negative/ no change trace results and discoloration of the ketone strips.Customer complaint was received via email stating that "purchased a pack of two containers of ketone strips and using one container all was fine, accidently jumped over to other container and the reactive was not there.The tip is even a different color.The container was kept in the bathroom drawer so no excessive heat or cold or sun".The customer did not reported symptoms.Medical attention is not reported as a result of the actual blood glucose results.The ketone test strip lot manufacturer¿s expiration date is 07/31/2021 and open vial date is undisclosed.

Manufacturer Narrative

Sections with additional information as of 7-jan-2021: h10: ketone test strips were returned for evaluation.Defect found on returned strips: physical defect of strips and discolored grey pads.Rc-061: storage outside specifications.

• 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: 10947287
• MDR Text Key: 243579160
• Report Number: 1000113657-2020-00874
• 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: 01/07/2021

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: 07/31/2021
• Device Model Number: STRIP, WALGREENS 100CTKETONE #383239
• Device Lot Number: AW560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Distributor Facility Aware Date: 11/09/2020
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1