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

Model Number	TRUEMETRIX
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Product not returned for evaluation.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip udi#: (b)(4).Note: manufacturer contacted customer in a follow-up call to ensure that the customer symptoms improved - able to establish contact with customer who indicated that symptoms improved and she is feeling well.At a later time manufacturer tried to make contact customer in a follow-up call to ensure that the replacement product is working as intended - unable to establish contact at this time.
Event or Problem Description
Consumer reported complaint for low and high blood glucose test results.The customer is concerned with tests results from results obtained of 69 and 162 mg/dl.The customer's expected fasting blood glucose test result range is 102 - 127 mg/dl.At the time of the call the customer reported feeling jittery.Customer stated she will eat since she had not eaten since 3pm and stated that she had felt jittery also when she had obtained the result of 69 mg/dl on (b)(6) 2019; customer had eaten something and felt fine after.Medical attention was not needed at the time of the call.During the call a blood test was performed by the customer fasting and produced test result of 113 mg/dl using meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 09/23/2019 and test strips were opened about one month ago.The meter memory was reviewed for previous test result history: (b)(6).
Event or Problem Description
Consumer reported complaint for low and high blood glucose test results.The customer is concerned with tests results from results obtained of 69 and 162 mg/dl.The customer's expected fasting blood glucose test result range is 102 - 127 mg/dl.At the time of the call the customer reported feeling jittery.Customer stated she will eat since she had not eaten since 3pm and stated that she had felt jittery also when she had obtained the result of 69 mg/dl on (b)(6) 2019; customer had eaten something and felt fine after.Medical attention was not needed at the time of the call.During the call a blood test was performed by the customer fasting and produced test result of 113 mg/dl using meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 09/23/2019 and test strips were opened about one month ago.The meter memory was reviewed for previous test result history: result 1: 113 mg/dl, date: (b)(6), time: 7:24pm fasting; result 2: 162 mg/dl, date: (b)(6), time: 5:21pm fasting; result 3: 103 mg/dl, date: (b)(6), time: 8:02am fasting; result 4: 133 mg/dl, date: (b)(6), time: 12:14am fasting; result 5: 69 mg/dl, date: (b)(6), time: 5:12pm fasting.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report #(b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip udi#: (b)(4).Manufacturer contacted customer in a follow-up call to ensure that the customer symptoms improved - able to establish contact with customer who indicated that symptoms improved and she is feeling well.At a later time manufacturer tried to make contact customer in a follow-up call to ensure that the replacement product is working as intended - unable to establish contact at this time.

• 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: 8511679
• Report Number: 1000113657-2019-00323
• Device Sequence Number: 19190562
• Product Code: NBW
• UDI-Device Identifier: 00021292007041
• UDI-Public: (01)00021292007041
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/28/2019

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: MV2829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/28/2019
• 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