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

Model Number STRIP, KETONE 50CT

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Note: manufacturer tried to make contact with the customer - e-mails were sent requesting customer to provide a contact phone number awaiting customer response.

Event Description

Consumer reported complaint via e-mail on 11/05/2020 for negative/no change trace results for the ketone test strips.Customer was wondering how exactly do you read the strip.Should it be in the dark colors are in the light colors if you're in ketosis.Customer went to the dr.And they did a finger stick and said i definitely was in ketosis but with this test it barely changed colors.No additional information was provided.

• 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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 10932727
• MDR Text Key: 219370633
• Report Number: 1000113657-2020-00865
• Device Sequence Number: 1
• Product Code: JIN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: STRIP, KETONE 50CT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/05/2020
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1