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

Model Number	TRUBALANCE
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	Hyperglycemia (1905); No Code Available (3191)
Date of Event	11/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-41- dead battery.(b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.Product notification letter sent for customer to contact customer care.(b)(4).
Event or Problem Description
Consumer reported complaint for dead meter.The expected fasting blood glucose test result range is undisclosed.The customer feels well and did not report symptoms at the time of call however on the follow up call the customer was having contractions and was on her way to the hospital.Possible medical attention is reported as a result of reported symptoms.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 06/13/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.We verified that no new battery was used.Meter does not turn on.On follow- up attempt on (b)(6) 2017; customer informed that she was on her way to the hospital due to a high result she obtained with another meter.Customer has gestational diabetes and is having contractions.Customer is four months pregnant.While customer was waiting for the new meter to arrive, she borrowed her friend meter to test.The results was 300mg/dl fasting.Due to the other meter's results of 300mg/dl fasting and the customer's symptoms (contractions), customer went to seeked medical intervention.Please note, customer has received new products however, has not use it yet.Unable to reach customer after several further follow up attempts.
Additional Manufacturer Narrative
(b)(4).Test strips not returned for evaluation.Returned meter evaluated with defect found.Qc investigation on (b)(6) 2018 resulted in dead meter.Final root cause: broken inductor due to user/mechanical stress.(b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.Product notification letter sent for customer to contact customer care.(b)(4).
Event or Problem Description
Consumer reported complaint for dead meter.The expected fasting blood glucose test result range is undisclosed.The customer feels well and did not report symptoms at the time of call however on the follow up call the customer was having contractions and was on her way to the hospital.Possible medical attention is reported as a result of reported symptoms.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 06/13/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.We verified that no new battery was used.Meter does not turn on.On follow- up attempt on (b)(6) 2017; customer informed that she was on her way to the hospital due to a high result she obtained with another meter.Customer has gestational diabetes and is having contractions.Customer is four months pregnant.While customer was waiting for the new meter to arrive, she borrowed her friend meter to test.The results was 300mg/dl fasting.Due to the other meter's results of 300mg/dl fasting and the customer's symptoms (contractions), customer went to seek medical intervention.Please note, customer has received new products however, has not use it yet.Unable to reach customer after several further follow up attempts.

• Brand Name: TRUBALANCE
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7100868
• Report Number: 1000113657-2017-02046
• Device Sequence Number: 16481782
• Product Code: NBW
• UDI-Device Identifier: 00021292003135
• UDI-Public: (01)00021292003135
• Combination Product (Y/N): N
• Initial Reporter State: PR
• PMA/510(K) Number: K090495
• 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
• Report Date (Section B): 03/05/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: TRUBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BT5060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/08/2017
• Supplement Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY; SECOND THERAPY