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

Model Number STRIP, WGN TMX 60CT 12/CASE MG/DL

Device Problem High Test Results (2457)

Patient Problems Hypoglycemia (1912); Syncope/Fainting (4411)

Event Date 02/15/2022

Event Type  Injury  

Event Description

Consumer reported complaint for high blood glucose test results.Son is calling on behalf of the customer.The customer is concerned with test results from results obtained of 238, 156, 105, 195 and 168 mg/dl.The customer does not know their expected blood glucose test result range.The customer feels well and did not report any symptoms.Past medical attention was reported; son stated that on (b)(6) 2022 customer had fainted and ems had been called.Customer was transported to the hospital where her blood glucose test result had been 18 mg/dl (fasting/non-fasting was not disclosed).The diagnosis was hypoglycemia; the medical treatment customer received was not disclosed.Customer remained in the er for six hours and then had been discharged; customer's blood glucose test result upon discharge was not disclosed.Customer had followed-up with her primary care physician.At that time, customer was taking tradjenta, glimepiride and glipizide.Customer's primary care physician had discontinued the glimepiride and the glipizide, but found that her blood glucose levels were ranging in the 200's, so the glipizide had been reinstated.During the call, a back to back blood test was not performed by the customer.The product is not stored according to specification (kitchen).The test strip lot manufacturer¿s expiration date is 03/29/2023 and open vial date is was not disclosed.The customer did not have another vial of test strips that had been stored and handled correctly.The meter memory was reviewed for previous test result history: (b)(6).

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-020: user's test strip had poor storage.Note: manufacturer contacted customer in a follow-up call on 10-mar-2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

Manufacturer Narrative

Sections with additional information as of 03-may-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: retention testing was performed using test strips from the same lot.Retention strips tested passed within specifications.

• 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: 13977488
• MDR Text Key: 288389067
• Report Number: 1000113657-2022-00186
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120
• 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: 05/03/2022

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/29/2023
• Device Model Number: STRIP, WGN TMX 60CT 12/CASE MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZY4483S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/07/2022
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 05/04/2022
• 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