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

Model Number TRUEMETRIX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Unspecified Infection (1930)

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reference report # (b)(4) (original customer complaint).Product not returned for evaluation.No replacement product needed at this time since customer stated that he is satisfied with the replacement product.Based on the confirmation of the glucose results from the hospital, product worked as intended.Most likely underlying root cause: mlc-18- user has high glucose value (b)(4).

Event Description

Manufacturer contacted customer in a follow-up call in order to ensure that the replacement products resolved the initial concern reported where customer's meter does not turn on.Customer's wife stated that the customer went to the er on (b)(6) 2017 due to symptoms of hyperglycemia with a blood glucose test readings of 500mg/dl fasting using customer's meter.Customer confirmed while at the hospital his blood glucose was also 500mg/dl fasting.

Manufacturer Narrative

(manufacturer narrative = t, corrected data = t) (b)(4).(original customer complaint) product not returned for evaluation.No replacement product needed at this time since customer stated that he is satisfied with the replacement product.Based on the confirmation of the glucose results from the hospital, product worked as intended.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi#(b)(4).Correction; correction made on the date received by manufacturer, the date the manufacturer received the new information for the reportable event was on 1/19/2018.

Event Description

Manufacturer contacted customer in a follow-up call in order to ensure that the replacement products resolved the initial concern reported where customer's meter does not turn on.Customer's wife stated that the customer went to the er on (b)(6) 2017 due to symptoms of hyperglycemia with a blood glucose test readings of 500mg/dl fasting using customer's meter.Customer confirmed while at the hospital his blood glucose was also 500mg/dl fasting.

• Brand Name: TRUEMETRIX
• Type of Device: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7221374
• MDR Text Key: 98436811
• Report Number: 1000113657-2018-00099
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007829
• UDI-Public: (01)00021292007829(17)190131(10)MU2571
• Combination Product (y/n): N
• PMA/PMN Number: K140100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2571
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 01/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SECOND THERAPY; SECOND THERAPY
• Patient Outcome(s): Hospitalization