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

Model Number	TMETRIX PR
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Urinary Frequency / Polyuria (2275); Weight Changes (2607)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-56- user had an inaccurate reference: lab results: the end user is comparing results obtained from trividias' bgm system to the results from the laboratory.Test strip (b)(4).
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.Lab supervisor is calling on behalf of the customer; lab supervisor would not disclose customer's name.The customer is concerned with test results from results obtained of hi.Lab supervisor declined to provide the customer's expected blood glucose test result range.Lab supervisor stated that on (b)(6) 2017 when testing customer, a result of hi had been obtained.The customer was then admitted to the hospital due to the hi result and symptoms of frequent urination and weight loss.When at the hospital, the customer's glucose level with the hospital's meter was 350 mg/dl non-fasting; customer received an iv and after two-three hours had received a glucose result of 429 mg/dl non-fasting with the hospital's meter.Lab supervisor stated the patient received treatments while in the hospital on (b)(6) 2017 but does not know the specific treatments that were given.Lab supervisor could not continue the phone conversation due to restricted time and declined to answer further questions.During the call on (b)(6) 2017, a back to back blood test was not performed by the customer.The product is stored according to specification in the lab.The test strip lot manufacturer's expiration date is 07/19/2018 and open vial date is (b)(6) 2017.The meter memory was not reviewed for previous test result history.(b)(6) (lab supervisor) of (b)(6) called in states the meter is reading hi display for a patient they had which (b)(6) (lab supervisor) would not disclose patient's name.

• Brand Name: TMETRIX PR
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7130021
• Report Number: 1000113657-2017-02082
• Device Sequence Number: 19311873
• Product Code: NBW
• UDI-Device Identifier: 10612479210254
• UDI-Public: (01)10612479210254
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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 Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/19/2017

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?: No
• Operator of Device: Other
• Device Expiration Date: 07/19/2018
• Device Model Number: TMETRIX PR
• Device Catalogue Number: RE4H01P-43
• Device Lot Number: MU2325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization