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

Model Number	TRUEMETRIX
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	Fall (1848); Loss of consciousness (2418)
Date of Event	09/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-41- dead battery.(b)(4).Note: manufacturer contacted customer on 9/28/2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer condition improved.No symptoms or medical attention reported since the original call.Customer satisfied with the replacement product.
Event or Problem 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 passing out and falling.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 11/30/2018 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.On (b)(6) 2017, the customer states that she passed out and fell out of her wheelchair.Her husband called 911.When the paramedics arrived her blood sugar was 25mg/dl non- fasting.Paramedics administered glucose gel.Customer regained consciousness.They gave her a peanut butter sandwich and her blood sugar was 389mg/dl non- fasting.Paramedics did not transport patient to the hospital, they recommended that she continue to monitor her blood sugar.Customer could not have reached us on that friday because we were closed due to hurricane irma.Customer could not check her blood sugar because the meter was dead.Customer is not experiencing symptoms at the time of the call.
Additional Manufacturer Narrative
( internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-25- strip inserted backwards or upside-down test strip udi# (b)(4).Note: manufacturer contacted customer on 9/28/2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer condition improved.No symptoms or medical attention reported since the original call.Customer satisfied with the replacement product.
Event or Problem 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 passing out and falling.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 11/30/2018 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.On (b)(6) 2017, the customer states that she passed out and fell out of her wheelchair.Her husband called 911.When the paramedics arrived her blood sugar was 25mg/dl non- fasting.Paramedics administered glucose gel.Customer regained consciousness.They gave her a peanut butter sandwich and her blood sugar was 389mg/dl non- fasting.Paramedics did not transport patient to the hospital, they recommended that she continue to monitor her blood sugar.Customer could not have reached us on that friday because we were close due to hurricane irma.Customer could not check her blood sugar because the meter was dead.Customer is not experiencing symptoms at the time of the call.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-25- strip inserted backwards or upside-down test strip udi# (b)(4).Note: manufacturer contacted customer on 9/28/2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer condition improved.No symptoms or medical attention reported since the original call.Customer satisfied with the replacement product.Correction: correction made regarding the product returned.
Event or Problem 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 passing out and falling.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 11/30/2018and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.On (b)(6) 2017, the customer states that she passed out and fell out of her wheelchair.Her husband called 911.When the paramedics arrived her blood sugar was 25mg/dl non- fasting.Paramedics administered glucose gel.Customer regained consciousness.They gave her a peanut butter sandwich and her blood sugar was 389mg/dl non- fasting.Paramedics did not transport patient to the hospital, they recommended that she continue to monitor her blood sugar.Customer could not have reached us on that friday because we were close due to hurricane irma.Customer could not check her blood sugar because the meter was dead.Customer is not experiencing symptoms at the time of the call.

• Brand Name: TRUEMETRIX
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 6939688
• Report Number: 1000113657-2017-01788
• Device Sequence Number: 807825
• Product Code: NBW
• UDI-Device Identifier: 00041220001286
• UDI-Public: (01)00041220001286
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2017

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
• Operator of Device: Lay User/Patient
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 09/18/2017; 09/18/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 10/23/2017; 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1