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

Model Number TRUEMETRIX

Device Problem Low Test Results (2458)

Patient Problems Emotional Changes (1831); Paresis (1998); Lethargy (2560)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) internal report: # (b)(4).Product not returned for evaluation.Most likely underlying root cause: mlc-28 there was not enough information to determine the mlurc.Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the customer symptoms improved - unable to establish contact at this time.Product notification letter sent to contact customer care.

Event Description

Consumer reported complaint for low blood glucose test results.Mother is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.Customer is not having any diabetic symptoms and does not need any medical attention at the time of the call.Caller did advise that son was sleeping during this time and could not troubleshoot.When mother wake up, the customer had symptoms of being lethargic, unable to move and enraged.Medical attention was reported, mother called 911 - mother would not disclose additional information.The product storage location is undisclosed.During the call a blood test was not performed.The test strip lot manufacturer's expiration date is undisclosed and open vial date is undisclosed.Caller proceeded to disconnect call, so additional information could not be obtained.The meter memory was not reviewed for previous test result history.

• 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: 8536181
• MDR Text Key: 145113548
• Report Number: 1000113657-2019-00366
• 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: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/22/2019
• 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