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

Model Number STRIP, TMX CVS 100CT 12/CASE MG/DL

Device Problem High Test Results (2457)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)

Event Date 08/06/2021

Event Type  Injury  

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 31-aug-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

Event Description

Consumer reported complaint for hi and high blood glucose test results.The customer is concerned with test results from results obtained of hi and 570 mg/dl.The customers expected am fasting blood glucose test result range is 180-230 mg/dl and expected pm fasting blood glucose test result range is 230-250 mg/dl.The customer feels well and did not report any symptoms.Customer stated she had gone to the hospital on (b)(6) 2021 due to the high blood glucose test result obtained of 570 mg/dl.Customer stated she was not experiencing any symptoms at the time.Customer's blood glucose test result when at the hospital had been 235 mg/dl fasting.Customer did not receive any medical treatment and no diagnosis was provided.There were no recommended changes to customer's medical treatment plan.During the call, a back to back blood test was performed by the customer non-fasting and produced test results of 245 mg/dl and 260 mg/dl using true metrix meter.The product is stored according to specification in the bedroom.The test strip lot manufacturers expiration date is 05/19/2022 and open vial date is (b)(6) 2021.The meter memory was reviewed for previous test result history: (b)(6).

Manufacturer Narrative

Sections with additional information as of 14-oct-2021: d9: device available for evaluation.H3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: meter and test strips were returned for evaluation.Product testing was performed and no defect found.Most likely underlying root cause: mlc-018: user has high glucose value.

• Brand Name: TRUE METRIX
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 12421235
• MDR Text Key: 269792899
• Report Number: 1000113657-2021-00535
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836
• Combination Product (y/n): N
• PMA/PMN Number: K140100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/19/2022
• Device Model Number: STRIP, TMX CVS 100CT 12/CASE MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZX4138S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Distributor Facility Aware Date: 08/19/2021
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization