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

Model Number TRUMETRXGO

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

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

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.

Event Description

Consumer reported complaint for erratic and low blood glucose test results.The customer is concerned with tests results from back to back blood tests of 31 and 225 mg/dl.Customer stated she did not have any symptoms when the results had been obtained.The customer's expected fasting non-fasting blood glucose test result range is 190 - 205 mg/dl.At the time of the call, the customer felt well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call on (b)(6) 2018, a back to back blood test was not performed by the customer.The product is stored according to specification in the living area.The test strip lot manufacturer's expiration date is 01/31/2019 and open vial date is two weeks.The meter memory was reviewed for previous test result history: result 1:231mg/dl, (b)(6) 6:34pm, fasting; result 2:203mg/dl, (b)(6) 6:34pm, fasting; result 3:209mg/dl, (b)(6) 3:34pm, fasting; result 4:215mg/dl, (b)(6) 3:31pm, fasting; result 5:203mg/dl, (b)(6) 3:30pm, fasting.

• Brand Name: TRUMETRXGO
• 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: 7663739
• MDR Text Key: 113188468
• Report Number: 1000113657-2018-00722
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007706
• UDI-Public: (01)00021292007706
• Combination Product (y/n): N
• PMA/PMN Number: K143548
• 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: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2019
• Device Model Number: TRUMETRXGO
• Device Catalogue Number: RF4H01-01
• Device Lot Number: MU2572
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 06/11/2018
• 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
• Treatment: SECOND THERAPY