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

Model Number KETONE STRIPS

Device Problem Material Discolored (1170)

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

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) internal report: (b)(4).Ketone test strips were not returned for evaluation.Most likely underlying root cause: mlc-20: user's test strip had poor storage.Note: manufacturer contacted customer in a follow-up call to ensure that the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.

Event Description

Consumer reported complaint for ketone test strips discoloration.The customer did not report symptoms.Medical attention is not reported as a result of the physical defects of ketone strips.The product is not stored according to specification and it is stored in the bathroom.During the call, a ketone urine test was not performed by the customer.The ketone test strips lot manufacturer's expiration date is 11/20/2020 and open vial date is undisclosed.

• Brand Name: KETONE STRIPS
• 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: 8767748
• MDR Text Key: 151002829
• Report Number: 1000113657-2019-00706
• 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: 07/08/2019

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: 11/20/2020
• Device Model Number: KETONE STRIPS
• Device Lot Number: AW482
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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