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

Model Number TRUEMETRIX

Device Problem Battery Problem (2885)

Patient Problems Angina (1710); Headache (1880)

Event Date 01/18/2019

Event Type  malfunction  

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Customer declined replacement product at this time.Customer will get a new battery.Most likely underlying root cause: mlc-41 -dead battery test strip udi# (b)(4).Note: manufacturer contacted customer on 2/7/2019 in a follow-up call to ensure that the initial concern was resolved; customer stated that they got a new meter however they didn't start to use it yet.No symptoms or medical attention reported since the last call.

Event Description

Consumer reported complaint for dead meter accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of having a headache, feeling pain in her chest.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.Test strip lot manufacturer's expiration date is 05/20/2020 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer is complaining of dead meter.The meter is not coming on, the meter continues to beep.She states she is having a headache, feeling pain in her chest but she thinks she may just need to eat something.After troubleshooting the meter is still unresponsive.Customer will purchase a new battery.

• Brand Name: TRUEMETRIX
• 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: 8333399
• MDR Text Key: 139061093
• Report Number: 1000113657-2019-00118
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007928
• UDI-Public: (01)00021292007928
• 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
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV3004S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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