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

Model Number KETONE STRIPS

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

Internal report: (b)(4).Ketone test strips were returned for evaluation.No defect was detected.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 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 (color does not match chart on vial).The customer did not report symptoms.Medical attention is not reported.The product is not stored according to specification in the bathroom.During the call a back to back ketone urine test was not performed by the customer.The ketone test strip lot manufacturer's expiration date is 12/31/2019 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: 8893541
• MDR Text Key: 202256873
• Report Number: 1000113657-2019-00811
• 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: 08/14/2019

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: 12/31/2019
• Device Model Number: KETONE STRIPS
• Device Lot Number: AV430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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