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

Model Number STRIP, TMX WGN 100CT12/CS MG/DL #383569

Device Problem High Test Results (2457)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 09/10/2022

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were returned for evaluation.Product testing was performed and no defect found.Most likely underlying root cause: mlc-055: user had an inaccurate reference: competitor¿s meter: the end user is comparing results obtained from trividia¿s bgm system to the results from a competitor¿s bgm system.Note: manufacturer contacted customer in a follow-up call on 16-sep-2022 to ensure the customer's condition had improved and that the replacement products resolved the initial concern.Able to establish contact with customer who stated she had been discharged from the hospital on (b)(6) 2022.At the time of the follow-up call the customer was not having any diabetic symptoms.Customer stated that the replacement products resolved the initial concern.

Event Description

Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 328 mg/dl.The customer does not know their expected blood glucose test result range.Customer had purchased the true metrix meter on (b)(6) 2022; customer stated that she had gone to the doctor where she had been diagnosed as a diabetic.Customer stated that a blood test had been performed at the doctor's office.Customer stated on (b)(6) 2022 the doctor had contacted her to advise she go to the hospital, as her a1c was 11.2 and she had ketones.At the time of the call the customer was currently in the hospital.Customer stated she had been diagnosed with dka and was being treated with insulin.Customer stated that the true metrix results were higher than the hospital's device.Customer stated that she had obtained a pm fasting result of 328 mg/dl using the true metrix meter and the result using the hospital's device had been 248 mg/dl.During the call, a back to back blood test was not performed by the customer.The product is stored according to specification.The test strip lot manufacturer¿s expiration date is 01/20/2024 and open vial date is 09/07/2022.The meter memory was reviewed for previous test result history (time not set): result 1: 328 mg/dl, date: (b)(6) 2022, time: 11:27 am, fasting pm ; result 2: 201 mg/dl, date: (b)(6) 2022, time: 8:12 am, unknown; result 3: 145 mg/dl, date: (b)(6) 2022, time: 2:34 am, fasting am; result 4: 176 mg/dl, date: (b)(6) 2022, time: 12:00 am, fasting am; result 5: 244 mg/dl, date: (b)(6) 2022 , time: 10:09 pm, fasting pm.

Manufacturer Narrative

Sections with additional information as of 07-nov-2022: h6: updated fda¿s type, findings and conclusions codes.H10: retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: (b)(6): user had an inaccurate reference: competitor¿s meter: the end user is comparing results obtained from trividia¿s bgm system to the results from a competitor¿s bgm system.

• 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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 15565325
• MDR Text Key: 301476396
• Report Number: 1000113657-2022-00527
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/20/2024
• Device Model Number: STRIP, TMX WGN 100CT12/CS MG/DL #383569
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZA4851S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/13/2022
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization