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

Model Number	TRUBALANCE
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Returned meter evaluated with no defect found.Test strip vial returned expired - unable to test.Most likely underlying root cause: mlc-12- product expired.The test strips referenced in this report are part of recall #1052693-06/13/16-001-r.Test strip (b)(4).Note: manufacturer contacted customer on 12/18/2017 in a follow-up call in order to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention since the last call.
Event or Problem Description
Consumer reported complaint for low blood glucose results.The customer is concerned with results obtained of 119, 133 and 110 mg/dl.The expected fasting blood glucose test result range is 175 to 220 mg/dl.The customer feels well and did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored by customer according to specification in the bedroom.During the call on (b)(6) 2017, a back to back blood test was performed non-fasting by the customer and produced test results of 181 and 185 mg/dl using true balance meter.The test strip lot manufacturer's expiration date is 12/15/2017 and open vial date is 2 weeks ago.The test the meter memory was reviewed for previous test result history: (b)(6).Customer called in states the meter is reading low after meals.Customer is concerned that fasting results obtained after meals of 119 mg/dl, 133 mg/dl and 110 mg/dl are too low for her especially if she has eaten food she should not have eaten.Customer is storing test strips correctly and states she opened a new vial (lot bt5047) and her reading are fine.Customer is aware vial will soon expire in a few days but states strips should still produce an accurate reading.Customer denies the need for medical attention at the time of call and denies signs and symptoms of hyperglycemia at the time of call.Customer did verify that she is testing at least 2 hours after her meals before eating her next meal and she feels the readings are too low.

• 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: 7167543
• Report Number: 1000113657-2018-00025
• Device Sequence Number: 13796026
• Product Code: NBW
• UDI-Device Identifier: 00021292003135
• UDI-Public: (01)00021292003135
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 01/05/2018

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 Model Number: TRUBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BS4707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1