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

Model Number	TRUEMETRIX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Weakness (2145)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer declined replacement.Customer is using another device.Most likely underlying root cause: mlc-28-there was not enough information to determine the mlurc test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(4) 2018 in a follow-up call in order to ensure the customer's condition since the initial call; customer condition improved.Customer will returned the meter; they using another device.
Event or Problem Description
Consumer reported complaint for symptoms.Mother is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of not eating and feeling weak tired.Medical attention is reported as a result of the reported symptoms.The product storage location is undisclosed.During the call on (b)(6) 2018, a back to back blood test was not performed.The test strip lot manufacturer's expiration date is undisclosed and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Mother stated that daughter was not eating and was very weak and tired.The ambulance was called.Mother stated that daughter was hospitalized but does not recall blood glucose meter or lab results.Mother stated that daughter was in the hospital and then transferred to a rehab facility from the months of (b)(6) to (b)(6).Mother did not know the exact dates of the hospitalization and/or the exact dates that her daughter was in sent to rehab.Mother stated that she no longer uses that meter and purchased a new one for her daughter.Mother did state that she would return meter for investigation.Mother chose not to disclose further information.The customer is not experiencing symptoms and no medical attention is required at the time of call.Daughter is no longer in rehab.

• 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: 7629148
• Report Number: 1000113657-2018-00675
• Device Sequence Number: 11343871
• Product Code: NBW
• UDI-Device Identifier: 00021292006082
• UDI-Public: (01)00021292006082
• 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: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2018

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 Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• 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: 05/30/2018
• Initial Report FDA Received Date: 06/22/2018
• 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