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 Code	Dizziness (2194)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Returned meter evaluated with no defect found.Wrong test strips returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage (kitchen).Test strip (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.
Event or Problem Description
Consumer reported complaint for high blood glucose results.Nurse is calling on behalf of the customer.The customer is concerned with results obtained of 300 mg/dl.The expected fasting blood glucose test result range is 180 mg/dl.The customer feels well at time of call and did report prior symptoms of feeling faint and dizzy.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is not stored by customer according to specification in the kitchen.The test strip lot manufacturer's expiration date is 04/17/2019 and open vial date is approximately three weeks ago.The meter memory was reviewed for previous test result history: (date/time not stored correctly) (b)(6).Customer got some wrong results yesterday.Customer states that she ran a blood test and got result of 300 mg/dl fasting.She took some medicine and then her glucose drop too low.Customer states that she started to feel dizzy and about to faint, unable to walk/ wobbling.She then got something to eat and the result came up.Customer states that her glucose drop low because she took the medication base on the results the meter was given and then her sugar drop low.Nurse states that she almost (b)(6) and she does not fully remember.Customer does not remember how low her glucose dropped.

• 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: 7306698
• Report Number: 1000113657-2018-00250
• Device Sequence Number: 16719541
• Product Code: NBW
• UDI-Device Identifier: 00010939722447
• UDI-Public: (01)00010939722447
• Combination Product (Y/N): N
• Initial Reporter State: WA
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/01/2018

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: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1