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

Model Number	TRUEMETRIX
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-55 - user had an inaccurate reference: competitor's meter: the end user is comparing results obtained from trividia's bgm system to the results from a competitor's bgm system.Test strip (b)(4).Note: manufacturer contacted customer on 8/7/2018 in a follow-up call to ensure that the replacement products resolved the initial concern; customer states that the pharmacy replace the meter for her.Customer states that she is no longer using the truemetrix meter she started using a different meter and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for low blood glucose results.Grandmother is calling on behalf of the customer.The customer is concerned with all of the low results obtained.The expected fasting blood glucose test result range is 100 to 120mg/dl.The customer feels well and did not report symptoms.No medical attention is reported as a result of the actual blood glucose results.Product is stored by customer according to specification in the living room.During the call on (b)(6) 2018, a back to back blood test was not performed.The test strip lot manufacturer's expiration date is 10/13/2019 and open vial date is 7/25/2018.The meter memory was reviewed for previous test result history: (b)(6).Customer was advised by the pharmacist to take the meter to the hospital so that they can test it for her, so she did.Contact the customer and customer states that she took the meter to the hospital and they told her that the meter is giving the 40-60 points lower.Customer have only been using the meter for two days now.Customer state that the meter has been giving low results in the 60's mg/dl.Her granddaughter has not been having any symptoms pertaining to her blood sugar.They ran her blood test "and" the hospital, but she does not remember what the result was.Customer needs a meter asap; pharmacy will replace the meter for the customer.I spoke to the pharmacy and he did not want to send the meter back to us for investigation; he will send the meter in so that he can get credit for it.

• 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: 7802670
• Report Number: 1000113657-2018-00880
• Device Sequence Number: 16200369
• Product Code: NBW
• UDI-Device Identifier: 00010939719447
• UDI-Public: (01)00010939719447
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2018

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: MV2856
• 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: 07/27/2018
• Initial Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1