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

Model Number KETONE STRIPS

Device Problem Ambient Temperature Problem (2878)

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

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Product was returned and evaluated with no defect found.Most likely underlying root cause mlc-20 user's test strip had poor storage.Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact at this time.

Event Description

Customer reported complaint for physical defect of ketone strips.The customer stated when he removed some of the strips from the vial, the pad was falling off of the strip.Customer also stated while urinating on the pad on some of some of the strips, the pad is falling off.The customer did not report any symptoms or medical attention.The product is not stored according to specification and is stored in the bathroom.The ketone test strip lot manufacturer's expiration date is 06/25/2020 and open vial date is 03/31/2019.Customer stated the bottle had been sealed before opening.

• 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: 8558067
• MDR Text Key: 145240570
• Report Number: 1000113657-2019-00402
• 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: 04/26/2019

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: 06/25/2020
• Device Model Number: KETONE STRIPS
• Device Lot Number: AV460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/26/2019
• 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