MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. KETONE; BLOOD GLUCOSE SYSTEM

Model Number KETONE

Device Problem Material Discolored (1170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

Internal report: (b)(4).Ketone test strips were returned for evaluation.Defect was detected.Most likely underlying root cause: rc-061: storage outside specifications note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for discolored ketone strips.The expected fasting blood glucose test result range is undisclosed.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product storage location is undisclosed.During the call a back to back ketone test was not performed by the customer.The test strip lot manufacturer's expiration date is 01/31/2020 and open vial date is 08/09/2019.

• Brand Name: KETONE
• Type of Device: BLOOD GLUCOSE SYSTEM
• 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 ; 954677-920
• MDR Report Key: 8961856
• MDR Text Key: 202735886
• Report Number: 1000113657-2019-00876
• Device Sequence Number: 1
• Product Code: JIN
• Combination Product (y/n): N
• PMA/PMN Number: K000000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/04/2019

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 Expiration Date: 01/31/2020
• Device Model Number: KETONE
• Device Lot Number: AV441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1