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

Model Number	STRIP, RLN TMX 100CTMG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Hyperglycemia (1905); Shaking/Tremors (2515)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-58: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.Product notification letter sent to contact customer care.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from all the results obtained.The expected fasting blood glucose test result range is 90mg/dl.The customer did report symptoms.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.Customer was admitted to the hospital on (b)(6) 2020.Customer stated she was feeling tired so she drove herself to the hospital on (b)(6) 2020 due to getting higher than normal results from her meter.Customer was still in the hospital during initial call and is expected to be discharged on (b)(6) 2020.Customer was diagnosed with high blood sugar.Customer was admitted and stated that her insulin was changed.The product is stored according to specification in the bedroom.During the call a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 11/20/2021 and open vial date is 7/13/2020.The meter memory was reviewed for previous test result history.(b)(6).

• 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: 10417623
• Report Number: 1000113657-2020-00585
• Device Sequence Number: 2757654
• Product Code: NBW
• UDI-Device Identifier: 00021292012236
• UDI-Public: (01)00021292012236
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 08/17/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/20/2021
• Device Model Number: STRIP, RLN TMX 100CTMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MX4245S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/17/2020
• 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: Hospitalization