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

Model Number STRIP, LEADER TMX 50CTMM MG/DL

Device Problem High Test Results (2457)

Patient Problems Hypoglycemia (1912); Hypothermia (1915); Shaking/Tremors (2515); Confusion/ Disorientation (2553); Speech Disorder (4415)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Adverse event report is being submitted due to medical attention.Test strips were not returned for evaluation.Meter was returned for evaluation.Reported defect not reproduced.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 made several attempts to contact customer to ensure the replacement products resolved the initial concern - unable to establish contact with customer.

Event Description

Consumer reported complaint for high blood glucose test results.Pharmacist and wife are calling on behalf of the customer.The customer is concerned with test results from results obtained of 142mg/dl.The customer¿s expected am fasting blood glucose test result is 130mg/dl.At the time of the call, the customer felt well and did not report any symptoms.Customer's wife stated that morning when he had obtained the result of 142mg/dl, customer was having symptoms of slurred speech, confused, shaky, cold and his body temperature dropped to 92 degrees.Customer was taken to the hospital; at the hospital, wife stated that customer's blood glucose level was unreadable, it ''was too low''.Wife stated that blood glucose test was taken 10-15 minutes from the time customer had obtained the result of 142mg/dl fasting at home.Customer was treated with an iv of sugar water and was given a heated blanket to raise his body temperature.Before customer was discharged, his blood glucose test result was 120mg/dl and his body temperature was 95 degrees.Customer was discharged the same day and was instructed to follow up with his doctor.During the call, a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 05/25/2022.Product storage and open vial date were not disclosed.The meter memory was reviewed for previous test result history: result 1: 142 mg/dl, date: (b)(6), time: 08:00 am, fasting; result 2: 127 mg/dl, date: (b)(6), time: 08:14 am, fasting; result 3: 123 mg/dl, date: (b)(6), time: 07:53 am, fasting; result 4: 138 mg/dl, date: (b)(6), time: 08:04 am, fasting; result 5: 116 mg/dl, date: (b)(6), time: 08:00 am, fasting.

• 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: 13088401
• MDR Text Key: 286595257
• Report Number: 1000113657-2021-00796
• 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,Health Professional
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/25/2022
• Device Model Number: STRIP, LEADER TMX 50CTMM MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZX4154S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Distributor Facility Aware Date: 12/01/2021
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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