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

Model Number	KIT, TMX NFRS STARTERMG/DL
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	Hypoglycemia (1912); Syncope/Fainting (4411)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was returned for investigation.No defect found.Test strips were not returned for evaluation.Most likely underlying root cause: mlc-041 dead battery.Note: manufacturer attempted to contact customer on several occasions to ensure the replacement products resolved the initial concern -unable to establish contact with customer.
Event or Problem Description
Consumer reported complaint for battery problem, stating that the true metrix meter was powering on and then shutting off.Customer stated the battery had been changed over three years ago.During the call the true metrix meter powered on using the power button and when a test strip was inserted; the "low battery" symbol was on.At the time of the call the customer felt well and did not report any symptoms.Customer stated she had called the ambulance the night before; customer stated she had felt lightheaded and was sweating.Customer stated she tested and obtained a blood glucose test result of 53mg/dl fasting about 2 1/2 hours after her dinner about 9 pm.Customer had called the ambulance and stated that she drank a (b)(6).When the emt's had arrived they had performed a blood glucose test and obtained a result of 126mg/dl.The diagnosis had been low blood sugar.Customer had declined going to the hospital.Customer did not receive any medical treatment and was advised to continue to monitor blood sugar.The test strip lot manufacturer¿s expiration date is 05/20/2022 and open vial date is undisclosed.

• 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: 11567641
• Report Number: 1000113657-2021-00201
• Device Sequence Number: 17009212
• Product Code: NBW
• UDI-Device Identifier: 00021292006075
• UDI-Public: (01)00021292006075
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/25/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/20/2022
• Device Model Number: KIT, TMX NFRS STARTERMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZX4142S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Distributor Facility Aware Date: 02/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/25/2021
• 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