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

Model Number STRIP, TMX HNO 50CT24/CS MG/DL

Device Problem Low Test Results (2458)

Patient Problems Hyperglycemia (1905); Muscle Weakness (1967); Ambulation Difficulties (2544); Polydipsia (2604); Decreased Appetite (4569)

Event Date 05/04/2022

Event Type  Injury  

Event Description

Consumer reported complaint for low blood glucose test results.Wife is calling on behalf of the customer.The customer is concerned with test results from meter to meter comparison of 220 mg/dl fasting using true metrix meter and hi using another device; wife stated the tests had been performed approximately 15 minutes apart.The customer¿s expected am fasting blood glucose test result range is 88-110 mg/dl and expected pre-lunch/dinner fasting blood glucose test result range is 100-150 mg/dl.The customer feels well and did not report any symptoms.When the customer had obtained the blood glucose test result of 220 mg/dl fasting on (b)(6) 2022, wife stated he had been experiencing symptoms at the time of extreme thirst, weakness, difficulty walking and was not eating.The paramedics had been called and when they tested the customer's blood glucose using their meter the result had been hi.The customer was transported to the hospital where his blood glucose test result was over 700 mg/dl.The diagnosis was hyperglycemia and customer was treated with iv fluids and insulin.The customer was discharged and was advised to follow-up with his physician.During the call, a back to back blood test was not performed by the customer.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 06/30/2023 and open vial date is one week prior to call.The meter memory was not reviewed for previous test result history.

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Manufacturer Narrative

Sections with additional information as of 05-jul-2022: h6: updated fda¿s type, findings and conclusions codes.H10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot passed within specifications.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.

• 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: 14547910
• MDR Text Key: 292973699
• Report Number: 1000113657-2022-00308
• 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: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Model Number: STRIP, TMX HNO 50CT24/CS MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZY4612S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/05/2022
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 06/09/2022
• Supplement Dates FDA Received: 07/05/2022
• 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