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	12/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Unable to establish contact with the customer to replace the meter and get product back for investigation - manufacturer has made several attempts.Manufacturer contacted customer (several attempts) in a follow-up call in order to ensure customer's condition - unable to establish contact with the customer at this time.Most likely underlying root cause of malfunction: user had an inaccurate reference.Note: several follow-up call were made in an effort to contact the customer; was unable to establish contact with customer.Left message on customer's voicemail.
Event or Problem Description
Customer sent an email 12/4/16 which states, "i have a meter that i think is giving me a false reading.It seems to be reading hi.The other day it was 243 in the am and i took 45 units nph n which i take every morning ate small orange and yogurt short time latter become dizzy whet to er they took my blood sugar it was only 70 i think it has been reading wrong lately is their someway i can check to make sure it is accurate?" an email response was sent to the customer apologizing for the inconvenience and requesting a call back due to a phone number not being provided.Customer called on (b)(6) 2016 regarding concern with results and to find out customer's condition, with no answer.Meter information was obtained when customer called in and left a message.

• 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: 6212655
• Report Number: 1000113657-2016-02111
• Device Sequence Number: 10978348
• Product Code: NBW
• UDI-Device Identifier: 00087701426520
• UDI-Public: (01)00087701426520
• Combination Product (Y/N): N
• 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): 12/29/2016

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: N/A
• 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: 12/06/2016
• Initial Report FDA Received Date: 12/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY
• Outcome Attributed to Adverse Event: Hospitalization