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

Model Number	TRUEMETRIX
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Codes	Dehydration (1807); Hyperglycemia (1905)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Customer is satisfied with the glucose meter.Most likely underlying root cause: mlc-9-use error caused or contributed to event test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(4) 2018 in a follow-up call in order to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention since the last call.
Event or Problem Description
Consumer reported complaint for rusty strips and previous medical attention.The expected fasting blood glucose test result range is undisclosed.The customer feels well and did not report symptoms.Medical attention is reported on a previous event.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 02/28/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer's daughter called in stating she had two strips in the container that looked rusty.On (b)(6) 2018, customer checked her blood sugar in the morning and the results was 248mg/dl fasting.Customer checked her blood sugar in the evening and results were 326mg/dl fasting.Customer's daughter drove her to the er, she was admitted and diagnosed with hyperglycemia and dehydration.Daughter does not remember her labs at the hospital, but believes they were matching the meter's results.Customer was released on (b)(6) 2018 and with an increased on her lantus.Customer declined replacement of the products stating that she believes the results were accurate and that she has purchased another true metrix meter just in case.

• 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: 7506643
• Report Number: 1000113657-2018-00542
• Device Sequence Number: 1556171
• Product Code: NBW
• UDI-Device Identifier: 10612479210261
• UDI-Public: (01)10612479210261
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 05/11/2018

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
• Device Lot Number: MU2621
• 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: 04/17/2018
• Initial Report FDA Received Date: 05/11/2018
• 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