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

Model Number TRUEMETRIX

Device Problem High Test Results (2457)

Patient Problems Neuropathy (1983); Blurred Vision (2137); No Code Available (3191)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: (b)(4)-user's test strip had poor storage.(kitchen).(b)(4).Customer reported symptom of stress.Test strip udi# (b)(4).Note: at call back on (b)(6) 2017, the customer's condition remained the same since the time of initial contact.The customer reported symptoms of blurred vision, stress and neuropathy in feet, an intense feeling of burning sensation.The customer did not receive any medical intervention since the last call.There were no additional blood tests performed with the truemetrix meter.Unable to contact the customer via telephone at call backs on 12/11/2017 and 12/12/2017.Product notification letter sent to customer to contact customer care.

Event Description

Consumer reported complaint for high blood glucose test results.Wife is calling on behalf of the customer.The customer is concerned with test results from results obtained of 130, 142, 144, 137 and 123 mg/dl.The customer's expected fasting blood glucose test result range is 80 - 100 mg/dl.At the time of the call the customer reported symptoms of blurred vision, stress, neuropathy in feet, an intense feeling of burning sensation.Customer denied the need for medical attention at the time of the call.During the call on (b)(6) 2017, a back to back blood test was performed by the customer fasting and produced test results of 142 mg/dl and 130 mg/dl using truemetrix meter.The product is not stored according to specification and is stored in the kitchen.The test strip lot manufacturer's expiration date is 02/28/2019 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history (date/time not set; results from log book): result 1 :130mg/dl date: (b)(6) 2017 time:11:55am fasting.Result 2 :142mg/dl date: (b)(6) 2017 time:11:50am fasting.Result 3 :144mg/dl date: (b)(6) 2017 time:11:30am fasting.Result 4 :137mg/dl date: (b)(6) 2017 time:11:27am fasting result 5 :123mg/dl date: (b)(6) 2017 time:11:25am fasting.

• 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: 7146583
• MDR Text Key: 96028924
• Report Number: 1000113657-2017-02115
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292006075
• UDI-Public: (01)00021292006075
• 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: Replace
• Type of Report: Initial
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2616
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 12/07/2017
• 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