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

Model Number	TRUBALANCE
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2017
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 of malfunction: strip issue.Note: manufacturer contacted customer on (b)(6) 2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer state that she improved a lot.She feels fine no symptoms present and no medical attentions since her new glucose management regiment.
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.The customer is concerned with tests results from results obtained of hi.The customer's expected fasting blood glucose test result range is 250 to 350mg/dl.The customer feels reported symptom of feeling tired.The product is stored according to specification.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The test strip lot manufacturer's expiration date is 10/27/2018 and open vial date is 12/27/2016.The meter memory was reviewed for previous test result history: hi (b)(6) 2017 01:09:00 pm fasting: yes; hi (b)(6) 2017 09:58:00 pm fasting: yes; 174mg/dl (b)(6) 2017 11:32 am fasting: yes; 544mg/dl (b)(6) 2017 11:04 am fasting: yes; 468mg/dl (b)(6) 2017 07:37 pm fasting: yes.Made a follow-up call was made in an effort to ensure the customers new replacement products is not hi as previously stated by the customer.I contacted customer and customer states that she is still getting the hi result on the meter.Customer states that she knows that her glucose have been high lately., customer states that she had spoken to her dr.A week ago and he called and prescribed lantis for her and she started taking the lantis on (b)(6) 2016.Customer states that she is feeling tired but does not request any medical assistance.Customer will be following back up with the doctor.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: strip issue.Note: manufacturer contacted customer on 1/5/2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer state that she improved a lot.She feels fine no symptoms present and no medical attentions since her new glucose management regiment.
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.The customer is concerned with tests results from results obtained of hi.The customer's expected fasting blood glucose test result range is 250 to 350 mg/dl.The customer feels reported symptom of feeling tired.The product is stored according to specification.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The test strip lot manufacturer's expiration date is 10/27/2018 and open vial date is (b)(6) 2016.The meter memory was reviewed for previous test result history: (b)(6).Made a follow-up call was made in an effort to ensure the customers new replacement products is not hi as previously stated by the customer.I contacted customer and customer states that she is still getting the hi result on the meter.Customer states that she knows that her glucose have been high lately., customer states that she had spoken to her dr.A week ago and he call had prescribe lantis for her and she started taking the lantis on (b)(6) 2016.Customer states that she is feeling tired but does not request any medical assistance.Customer will be following back up with the doctor.

• 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: 6289412
• Report Number: 1000113657-2017-00159
• Device Sequence Number: 19223342
• Product Code: NBW
• UDI-Device Identifier: 00021292007959
• UDI-Public: (01)00021292007959(17)181027(10)BT4908
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: TRUBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BT4908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 02/15/2017
• 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