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

Model Number STRIP, TRUE METRIX NFRS 24/CS 50CT MG/DL

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Weakness (2145)

Event Date 12/04/2019

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-28: there was not enough information to determine the mlurc.Note: manufacturer contacted customer in a follow-up call to ensure that the customer's condition improved - unable to establish contact with customer at this time.No product notification letter sent since no customer address on file.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - un/able to establish contact with customer at this time.

Event Description

Consumer reported complaint for erratic blood glucose test results.The customer is concerned with test results from back to back blood tests of 120 and 153 mg/dl; customer was not able to confirm if tests were performed fasting or non-fasting.The customer stated his expected fasting blood glucose test result is in the 130's.At the time of the call the customer reported feeling weak and "out of it." medical attention was not needed at the time of the call.During the call, a back to back blood test was performed by the customer non-fasting and produced test results of 123 mg/dl and 125 mg/dl using meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 04/22/2021 and the test strips were opened two weeks ago.The meter memory was reviewed for previous test result history: (b)(6).

Manufacturer Narrative

Sections with additional information as of 20-feb-2020: h6: updated fda's method, result, and conclusion 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 tested and passed.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.

• 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: 9531755
• MDR Text Key: 187438975
• Report Number: 1000113657-2019-10262
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836
• Combination Product (y/n): N
• PMA/PMN Number: K150052
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/22/2021
• Device Model Number: STRIP, TRUE METRIX NFRS 24/CS 50CT MG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MW3548S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/04/2019
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1