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

Model Number	TRUEMETRIX
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage(kitchen).Test strip udi# (b)(4).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 high and low blood glucose test results.The customer is concerned with tests results from results obtained of 273 and 39 mg/dl fasting, 229 and 246 mg/dl non-fasting.The customer's expected fasting blood glucose test result range is 100 - 200 mg/dl; expected non-fasting range was not provided.At the time of the call, the customer felt well and did not report any symptoms.Customer stated that a month and a half ago (does not recall date), he had symptoms of low blood sugar, was incoherent and not responding.An ambulance was called, the diagnosis was hypoglycemia and customer was given an iv for 30 minutes to elevate his blood sugar.Customer does not recall what his blood glucose test result was.Customer did not go to the hospital.Customer continued to use the truemetrix meter.During the call on (b)(6) 2018, a back to back blood test was not performed by the customer.The product is not stored according to specification and is stored in the kitchen.The test strip lot manufacturer's expiration date is 04/30/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: result 1 :229mg/dl date: (b)(6) 2018 time:11:10am non-fasting; result 2 :246mg/dl date: (b)(6) 2018 time:11:05am non-fasting; result 3 :273mg/dl date:(b)(6) 2018 time:10:09am fasting; result 4 :140mg/dl date:(b)(6) 2018 time:06:03am fasting; result 5 :39mg/dl date:(b)(6) 2018 time:02:28am fasting.

• 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: 8037595
• Report Number: 1000113657-2018-01129
• Device Sequence Number: 19213763
• Product Code: NBW
• UDI-Device Identifier: 00011822445610
• UDI-Public: (01)00011822445610
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 11/05/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2665
• 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: 10/10/2018
• Initial Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1