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

Model Number	KIT, MMS TMX STARTERMG/DL
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Hypoglycemia (1912)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 10-mar-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement meter was received but not the test strips.
Event or Problem Description
Consumer reported complaint for dead meter.Wife is calling on behalf of the customer.Customer has had the truemetrix meter for over a year had the battery has never been changed.During the call, the truemetrix meter did not power on using the power button or when a test strip was inserted.Customer's test strips were expired: manufacturer¿s expiration date is 09/19/2017.At the time of the call the customer felt well and did not report any symptoms.Wife reported that in (b)(6) 2020 customer had been hospitalized and the diagnosis had been atrial fibrillation and hypoglycemia.Wife also stated that customer does use another brand meter and could not confirm if customer was using the truemetrix meter at the time.No further information was provided.

• 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: 11543459
• Report Number: 1000113657-2021-00194
• Device Sequence Number: 14194504
• Product Code: NBW
• UDI-Device Identifier: 10612479210261
• UDI-Public: (01)10612479210261
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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: 09/19/2017
• Device Model Number: KIT, MMS TMX STARTERMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT1676
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/22/2021
• 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: Hospitalization