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	Headache (1880)
Date of Event	06/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: mlc-20 user's test strip had poor storage.(kitchen) test strip (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for high blood glucose results accompanied by symptoms.The customer is concerned with the non- fasting result of 249 m g/dl.The expected fasting blood glucose test result range is 85-100 mg/dl.The customer did report symptom of having a terrible headache.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 12/15/2017 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history.(b)(6).Customer called in to report high results on her meter.Customer states she has a terrible headache and denies medical attention.Customer realized that the high result was after she had breakfast but still believes it is too high, even after eating.
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: mlc-20 user's test strip had poor storage (kitchen).Test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for high blood glucose results accompanied by symptoms.The customer is concerned with the non- fasting result of 249mg/dl.The expected fasting blood glucose test result range is 85-100mg/dl.The customer did report symptom of having a terrible headache.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 12/15/2017 and open vial date is 04/29/2017.The meter memory was reviewed for previous test result history.(b)(6).Customer called in to report high results on her meter.Customer states she has a terrible headache and denies medical attention.Customer realized that the high result was after she had breakfast but still believes it is too high, even after eating.

• 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: 6728828
• Report Number: 1000113657-2017-01456
• Device Sequence Number: 13763810
• Product Code: NBW
• UDI-Device Identifier: 00096295126600
• UDI-Public: (01)00096295126600
• 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,Followup
• Report Date (Section B): 09/20/2017

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 Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT1845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1