MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUE METRIX; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number	METER, ARRIVA TMXMETER ONLY MG/DL
Medical Device Problem Codes	Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was returned for evaluation.No defect was detected.Test strips were not returned for evaluation.Most likely underlying root cause: mlc-44: user has low battery.Note: manufacturer contacted customer in a follow-up call on 20-may-2020 to ensure that the customer's condition improved - able to establish contact with customer and stated he no longer has symptoms and condition has improved.
Event or Problem Description
Consumer reported complaint for low battery accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.The customer did report symptom of feeling weak.Medical attention is reported as a result.The customer stated that on (b)(6) 2020, he went to the emergency room because he was feeling weak and tired due to his diabetes.The emergency room performed urine test the result was over 500 and also performed blood test result was 355 mg/dl.Customer was treated with insulin and was released after 4 hours in the emergency room.Customer was prescribed glipizide and to follow up with his doctor.Customer will have an appointment (b)(6) 2020 the product storage location is undisclosed.During the call, a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 07/30/2021 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.

• Brand Name: TRUE METRIX
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10159447
• Report Number: 1000113657-2020-00403
• Device Sequence Number: 3867378
• Product Code: NBW
• UDI-Device Identifier: 00021292007041
• UDI-Public: (01)00021292007041
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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): 06/16/2020

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: 06/30/2021
• Device Model Number: METER, ARRIVA TMXMETER ONLY MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MW4037S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Distributor Facility Aware Date: 05/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/16/2020
• 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: Required Intervention