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

Model Number TRUMETRXGO

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Swelling (2091); Blurred Vision (2137)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-21- improper technique of obtaining or applying blood sample.Test strip udi# (b)(4).Manufacturer contacted customer on (b)(6) 2018 in a follow-up call in order to ensure the customer's condition since the initial call; the customer's condition had improved and she did not currently have any diabetic symptoms.The customer did not have any medical intervention since the last call.No additional blood tests were performed using the truemetrix go meter.

Event Description

Consumer reported complaint for e-0 error: invalid hematocrit.The e-0 error occurred once the blood sample was absorbed.The error occurred with multiple test strips.Customer also stated that she had gone to the hospital last week due to the meter reading e-0.Customer stated her heart had been racing.Customer's blood glucose test result when at the hospital was 354 mg/dl.The diagnosis was hyperglycemia; customer stated the doctors could not find any issues with her heart but that it was due to her diabetes.The customer did not disclose if any treatment had been received.The customer did not remember the exact dates of hospitalization.At the time of the call on (b)(6) 2018, the customer reported having blurry vision and stated her eyes were swollen; customer stated that usually happens when her blood sugar is high.During the call on (b)(6) 2018, a blood test was performed by the customer fasting and produced test result of 189 mg/dl using truemetrix go meter; customer refused to perform another blood test.The customer's expected fasting blood glucose test result range is 80 - 100 mg/dl.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 05/15/2019 and open vial date is (b)(6) 2018.Customer refused to review the meter memory for previous test result history.

• 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: 7245067
• MDR Text Key: 99791752
• Report Number: 1000113657-2018-00150
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 021292006112
• UDI-Public: (01)021292006112
• 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: 02/06/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/15/2019
• Device Model Number: TRUMETRXGO
• Device Catalogue Number: RF4H01-01
• Device Lot Number: MU2678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization