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

Model Number STRIP, WALGREENS 100CTKETONE #383239

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned - customer declined replacement.Note: manufacturer contacted customer in a follow-up call to ensure the patient condition improved and initial concern is resolved - able to establish contact with customer who stated still having the same product and yes, product shows trace in urine.

Event Description

Consumer reported complaint for negative/no change trace results when using the ketone test strips.Customer uses the ketone strips for a keto diet and also stated that he was in deep ketosis with last ketone test strips he used and saw purple.Customer stated he had used all of those test strips and had purchased a new vial which shows that he is not in ketosis.At the time of the call the customer felt well and did not report any symptoms.No medical attention associated with the use of the product was reported.Customer declined to troubleshoot and to provide any further information.

Manufacturer Narrative

Corrected sections as of 24-feb-2021: d2:product code corrected from nbw to jin.D2: common device name: corrected from system, test blood glucose, over the counter to nitroprusside, ketones (urinary, non-quant).H6: conclusion corrected from 19 and 67 to only 19.

Manufacturer Narrative

Sections with additional information as of 23-feb-2021: 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 underline root cause - mlc-001 user had an inaccurate reference.Poor tech-inaccurate reference.

• 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: 11188262
• MDR Text Key: 240955324
• Report Number: 1000113657-2021-00041
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2021

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: 12/22/2021
• Device Model Number: STRIP, WALGREENS 100CTKETONE #383239
• Device Lot Number: AX586
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/23/2020
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/18/2021
• Supplement Dates Manufacturer Received: 02/02/2021; 02/02/2021
• Supplement Dates FDA Received: 02/23/2021; 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1