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	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet returned for evaluation.Customer will try to get a replacement at the pharmacy.Most likely underlying root cause of malfunction: mlc-20 user's test strip had poor storage.(kitchen) test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 226 mg/dl.The customer's expected fasting blood glucose test result range is 118 - 120 mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call on (b)(6) 2017, 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 09/14/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: the 226mg/dl (b)(6) 2017 03:01 am fasting: yes, the 226mg/dl (b)(6) 2017 02:32 am fasting: yes, the 215mg/dl (b)(6) 2017 02:08 am fasting: yes, the 189mg/dl (b)(6) 2017 02:07 am fasting: yes, the 167mg/dl (b)(6) 2017 07:10 am fasting: yes.Memory concerns: customer is concern with all these results customer states that the meter is giving her high blood results.Customer states that she have been a diabetic since 2002 and never had these high blood results before.Customer state that now the meter is giving high results in the 200smg/dl.Customer states that her normal glucose range 118-120mg/dl fasting.I offer to replace the meter but customer will try to get a new meter at the pharmacy.

• 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: 6676724
• Report Number: 1000113657-2017-01141
• Device Sequence Number: 16161119
• Product Code: NBW
• UDI-Device Identifier: 00010939722447
• UDI-Public: (01)00010939722447
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2017

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 Expiration Date: 09/14/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2386
• 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: 06/06/2017
• Initial Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1