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	Blurred Vision (2137); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for e-5 error code and hi display.The e-5 error occurred when the blood sample was absorbed.At the time of the call the customer reported symptoms of excessive thirst, blurry vision, frequent urination and feeling weak and tired.Medical attention was required and customer was going to call 911.Customer had called back on (b)(6) 2018, and further information was able to be obtained.The customer reported that his condition had improved and he did not currently have any diabetic symptoms.On (b)(6) 2018, the customer had called the ambulance.The customer's blood glucose test result when at the hospital was in the 700's.The customer was diagnosed with hyperglycemia and was given insulin.The customer was discharged the same day; no new medications or healthcare program was suggested.The customer is concerned with tests results of hi.The customer's expected fasting blood glucose test result range is 200 - 300 mg/dl.During the call on (b)(6) 2018, a back-to-back blood test was performed by the customer non-fasting and produced test results of 522 mg/dl and 520 mg/dl using truemetrix meter.The product is stored according to specification in the living room.The test strip lot manufacturer's expiration date is 05/27/2020 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (b)(6).
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) sections with additional information as of 29-apr-2020: h6: updated fda's method, result, and conclusion codes h10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested and passed.Internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for e-5 error code and hi display.The e-5 error occurred when the blood sample was absorbed.At the time of the call the customer reported symptoms of excessive thirst, blurry vision, frequent urination and feeling weak and tired.Medical attention was required and customer was going to call 911.Customer had called back on (b)(6) 2018 and further information was able to be obtained.The customer reported that his condition had improved and he did not currently have any diabetic symptoms.On (b)(6) 2018 the customer had called the ambulance.The customer's blood glucose test result when at the hospital was in the 700's.The customer was diagnosed with hyperglycemia and was given insulin.The customer was discharged the same day; no new medications or healthcare program was suggested.The customer is concerned with tests results of hi.The customer's expected fasting blood glucose test result range is 200 - 300 mg/dl.During the call on 12/11/2018, a back to back blood test was performed by the customer non-fasting and produced test results of 522 mg/dl and 520 mg/dl using truemetrix meter.The product is stored according to specification in the living room.The test strip lot manufacturer's expiration date is 05/27/2020 and open vial date is 12/10/2018.The meter memory was reviewed for previous test result history: result 1 :279mg/dl date:12/11/18 time:9:28am fasting.Result 2 :hi date:12/9/18 time:11:59am fasting.Result 3 :504mg/dl date:12/9/18 time:6:38am fasting.Result 4 :130mg/dl date:12/8/18 time:8:46am fasting.Result 5 :245mg/dl date:12/7/18 time:7:13pm fasting.

• 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: 8208276
• Report Number: 1000113657-2019-00003
• Device Sequence Number: 1657058
• Product Code: NBW
• UDI-Device Identifier: 00021292006051
• UDI-Public: (01)00021292006051
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/29/2020

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: Lay User/Patient
• Device Expiration Date: 05/27/2020
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV3022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 04/29/2020
• 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