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 Codes	Headache (1880); Dizziness (2194); Urinary Frequency / Polyuria (2275)
Date of Event	12/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not returned for evaluation.Customer declined replacement.Customer disconnect call.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).
Event or Problem Description
Consumer reported complaint for high blood glucose results accompanied by symptoms.The customer is concerned with meter to meter comparison results of 303 mg/dl using true metrix and 248 mg/dl using doctor's meter.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling dizzy, headache, increase urination.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is stored by customer according to specification in the office.During the call on (b)(6) 2017, a back to back blood test was not performed.The test strip lot manufacturer's expiration date is 11/30/2018 and open vial date is (b)(6) 2017.The meter memory was not reviewed for previous test result history.Result 1 :303 mg/dl (b)(6) 2017 11:30 am fasting (from log book) notified customer to please contact healthcare provider due to symptoms of hyperglycemia.Customer became vulgar and disconnected call.Could not obtain history of meter due to call being disconnected and unable to ship replacement products.On follow up attempt, customer refused to answer any questions.
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 : 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 udi# (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose results accompanied by symptoms.The customer is concerned with meter to meter comparison results of 303mg/dl using true metrix and 248mg/dl using doctor's meter.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling dizzy, headache, increase urination.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is stored by customer according to specification in the office.During the call on (b)(6) 2017, a back to back blood test was not performed.The test strip lot manufacturer's expiration date is 11/30/2018 and open vial date is (b)(6) 2017.The meter memory was not reviewed for previous test result history.(b)(6).Notified customer to please contact healthcare provider due to symptoms of hyperglycemia.Customer became vulgar and disconnected call.Could not obtain history of meter due to call being disconnected and unable to ship replacement products.On follow up attempt, customer refused to answer any questions.

• 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: 7210250
• Report Number: 1000113657-2018-00086
• Device Sequence Number: 122671
• Product Code: NBW
• UDI-Device Identifier: 00021292007065
• UDI-Public: (01)00021292007065
• 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,Followup
• Report Date (Section B): 02/05/2018

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: MU2490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 01/22/2018
• Supplement Report FDA Received Date: 02/05/2018
• 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; SECOND THERAPY