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

Model Number STRIP, TMX PBX 50CTMG/DL

Device Problem High Test Results (2457)

Patient Problems Headache (1880); Hyperglycemia (1905); No Code Available (3191)

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-58: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Note: manufacturer contacted customer in a follow-up call to ensure that the customer's condition improved - able to establish contact with customer and on follow-up call on 12/09/2019, the customer's condition had improved and she did not currently have any diabetic symptoms.Customer stated that she had a headache but that it was due to a mass on her brain and was unrelated to her diabetes.Customer stated that she had been hospitalized from (b)(6) 2019 - (b)(6) 2019.Customer's blood glucose test result when admitted to the hospital was 577 mg/dl; customer did not recall her diagnosis, only that hospital was concerned with her high glucose level.Customer was treated with iv fluids, a humalog pump, and lantus.Customer's blood glucose test result when discharged from the hospital was 357 mg/dl.Customer's levothyroxine was increased from 150 mcg to 175 mcg.Customer has tested using the truemetrix meter and obtained a result of 170 mg/dl fasting; customer was satisfied with the product.

Event Description

Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 577 and 549 mg/dl.The customer¿s expected blood glucose test result range was not provided.At the time of the call, the customer stated she felt tired, had a headache and had sweet breath.Customer stated that she knows her blood glucose is high was going to call 911.No further information was able to be obtained.

Manufacturer Narrative

Sections with additional information as of 20-feb-2020: 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 tested and passed.

• 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: 9535684
• MDR Text Key: 187439490
• Report Number: 1000113657-2019-10266
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Model Number: STRIP, TMX PBX 50CTMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MW4041S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/06/2019
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization