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

Model Number STRIP, WALGREENS DIETKETONE 50CT #104335

Device Problem Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Manufacturer contacted customer in three follow-up emails to obtain additional information and be able to support with the initial concern - unable to establish contact with customer at this time.

Event Description

Complaint received via email.Consumer reported complaint for physical defect of ketone test strips and stated that purchased a bottle of test strips at my local pharmacy and the batch that i received appears to be defective.All the strips in my bottle are purple to begin with or a purple gray color.No additional information was provided.

Manufacturer Narrative

Sections with additional information as of 18-mar-2021: d8: answered no.H6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using strips from the same lot.Retention strip lot tested and passed.Most likely underline 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: 11299139
• MDR Text Key: 231716060
• Report Number: 1000113657-2021-00090
• Device Sequence Number: 1
• Product Code: JIN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

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: 08/19/2021
• Device Model Number: STRIP, WALGREENS DIETKETONE 50CT #104335
• Device Lot Number: AX562
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/12/2021
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1