MAUDE Adverse Event Report: TRIVIDIA HEALTH INC KETONE; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number STRIP, KETONE 50CT

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

Ketone test strips were not returned for evaluation.Most likely underlying root cause: mlc-61: improper use / mishandled by end user.Note: manufacturer contacted customer in a follow-up call to ensure the customer's products are working as intended - unable to establish contact with customer at this time.No product notification letter sent since no customer address on file.

Event Description

Consumer reported complaint for negative/no change trace results of ketone strips.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.During the call a ketone test was not performed by the customer.The ketone test strip lot manufacturer¿s expiration date is undisclosed and open vial date is october 2019.

• Brand Name: KETONE
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• 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: 9284507
• MDR Text Key: 207223345
• Report Number: 1000113657-2019-10128
• Device Sequence Number: 1
• Product Code: JIN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K00000
• 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: 11/06/2019

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 Model Number: STRIP, KETONE 50CT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/11/2019
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/06/2019
• 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