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

Model Number	TRUBALANCE
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional 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.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.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.Customer is concerned with tests results from results obtained of 57 mg/dl.The customer also reported complaint for high control glucose test result.The customer's expected fasting blood glucose test result range is 105 - 150 mg/dl.The customer feels 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 performed by the customer non-fasting and produced test results of 326 mg/dl and 294 mg/dl using truebalance meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 05/21/2020 and open vial date is (b)(6) 2018.Test strips are not impacted by recall.The meter memory was reviewed for previous test result history: result 1 :57mg/dl date: (b)(6) 2018 time:08:43am fasting; result 2 :110mg/dl date: (b)(6) 2018 time:11:34am fasting; result 3 :105mg/dl date: (b)(6) 2018 time:11:32am fasting; result 4 :137mg/dl date: (b)(6) 2018 time:11:33am fasting; result 5 :158mg/dl date: (b)(6) 2018 time:12:21pm fasting.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.Customer is concerned with tests results from results obtained of 57 mg/dl.The customer also reported complaint for high control glucose test result.The customer's expected fasting blood glucose test result range is 105 - 150 mg/dl.The customer feels 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 performed by the customer non-fasting and produced test results of 326 mg/dl and 294 mg/dl using truebalance meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 05/21/2020 and open vial date is 08/22/2018.Test strips are not impacted by recall.The meter memory was reviewed for previous test result history: result 1 :57mg/dl date:(b)(6) 2018, time:08:43am fasting, result 2 :110mg/dl date:(b)(6) 2018, time:11:34am fasting, result 3 :105mg/dl date:(b)(6) 2018, time:11:32am fasting, result 4 :137mg/dl date: (b)(6) 2018, time:11:33am fasting, result 5 :158mg/dl date:(b)(6) 2018, time:12:21pm fasting.
Additional Manufacturer Narrative
(manufacturer narrative t, corrected data f) internal report (b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause mlc-57-user had an inaccurate reference: alternate meter: the end user is comparing results obtained from one of trividia's bgm system to the results from another trividia's bgm system 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.Product notification letter sent to customer to contact customer care.

• 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: 7878147
• Report Number: 1000113657-2018-00950
• Device Sequence Number: 2050194
• Product Code: NBW
• UDI-Device Identifier: 00021292007959
• UDI-Public: (01)00021292007959(17)200521(10)BU5203
• 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): 09/28/2018

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 Expiration Date: 05/21/2020
• Device Model Number: TRUBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BU5203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 09/28/2018
• 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