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

Model Number	TRUEMETRIX
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Fatigue (1849); Hypoglycemia (1912)
Date of Event	03/26/2018
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.Test strip udi# (b)(4).Manufacturer contacted customer (several attempts) in a follow-up call in order 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 high blood glucose results.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 120 mg/dl.The customer feels well on call but did report prior symptoms of feeling ill and tired.Medical attention is reported as a result of the reported symptoms.The product is stored by customer according to specification in the bedroom.During the call on (b)(6) 2018, a back to back blood test was performed non-fasting by the customer and produced test results of 269 and 287 mg/dl using true metrix meter.Test strip lot manufacturer's expiration date is 7/19/19 and open vial date is two weeks ago.The meter memory was reviewed for previous test result history: (date/time not stored correctly): (b)(6).Customer is concerned with both the high results and the erratic results that she is getting from her meter.Customer is not having any diabetic symptoms at this time.Customer reported an incident that occurred at the beginning of (b)(6) 2018.Customer was feeling ill and tired.Customer stated that she does not recall what date this occurred built advised that she was in the er for 5 hours and then released.Customer stated that she has still been using the allegedly defective meter since she went to the er.Her blood glucose reading at the hospital was 69 mg/dl/ and she was diagnosed with low blood glucose levels.Customer stated that she was given iv fluids.Customer stated that she was advised by the emergency room doctors to follow up with her primary care doctor.

• 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: 7441672
• Report Number: 1000113657-2018-00445
• Device Sequence Number: 1094636
• Product Code: NBW
• UDI-Device Identifier: 00050428275283
• UDI-Public: (01)00050428275283
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 04/18/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2751
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1