MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. N/A; BLOOD GLUCOSE SYSTEM

Model Number KETONE STRTIP

Device Problem Display Difficult to Read (1181)

Patient Problems Fatigue (1849); Lethargy (2560)

Event Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product was returned and evaluated - reported defect not reproduced.Most likely underlying root cause: mlc-1 user had an inaccurate reference.Note: manufacturer contacted customer in a follow-up call to ensure that the customer symptoms improved and replacement products resolved the initial concern - able to establish contact with customer who indicated his symptoms improved.Customer contacted at later time to find out about replacement product - unable to establish contact at this time.Product notification letter sent to contact customer care.

Event Description

Consumer reported complaint for negative/ no change trace results accompanied by symptoms.Customer just performed a test prior to calling and stated there was no changes in the ketone strips when testing.The customer did report symptoms of upset stomach, tired and lethargic.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms, she will most likely contact doctor for instruction.The product storage location is undisclosed.The ketone test strip lot manufacturer's expiration date is 07/16/2020 and open vial date is (b)(6) 2019.

• Brand Name: N/A
• 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: 8542081
• MDR Text Key: 142890286
• Report Number: 1000113657-2019-00379
• 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: 04/23/2019

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: 07/16/2020
• Device Model Number: KETONE STRTIP
• Device Lot Number: AV466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/23/2019
• 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