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

Model Number KIT, TRUE METRIX METERMG/DL

Device Problems Failure to Power Up (1476); Low Test Results (2458)

Patient Problems Abdominal Pain (1685); Nausea (1970)

Event Date 11/04/2022

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Adverse event report is being submitted due to customer contacting doctor due to true metrix meter not turning on.Meter and test strips were returned - product evaluation in-process.Note 1: manufacturer contacted customer in a follow-up call on 07-nov-2022 to ensure the customer's condition had improved - able to establish contact with customer who stated her condition had improved and she did not currently have any diabetic symptoms.No medical intervention since the last call was reported.Note 2: manufacturer contacted customer in a follow-up call on 14-nov-2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

Event Description

Consumer reported complaint for dead meter.At the time of the call the customer reported experiencing symptoms of nausea and stomachache; customer stated that when she feels those symptoms usually her blood sugar is low.Customer stated that she had contacted her doctor that morning to inform him the true metrix meter was not working; customer had not been experiencing symptoms at the time she had contacted the doctor.Customer had requested doctor provide her a new meter; doctor had referred customer to pharmacy and pharmacy referred to manufacturer.Customer received the true metrix meter 4 months prior and had not changed the battery.The customer is using the correct battery in the correct orientation for the meter.During the call the true metrix meter powered on using the power button and when a test strip was inserted.During the call, a blood test was performed by the customer non-fasting and produced test result of 114 mg/dl using true metrix meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 11/30/2023 and test strips were open a few days prior.

Manufacturer Narrative

Sections with additional information as of: 03-jan-2023: h3: device evaluated by manufacturer.H6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: meter and strips were returned for evaluation.Defect found on returned strips: high readings.Reported defect not reproduced on returned meter.Returned product was forwarded to r&d chemistry for root-cause.R&d investigation has been completed and root cause selected.Retention strip lot tested within specifications.Root cause: rc-061: storage outside 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: 15905130
• MDR Text Key: 308146106
• Report Number: 1000113657-2022-00618
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007690
• UDI-Public: (01)00021292007690
• 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: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/03/2023

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: 11/30/2023
• Device Model Number: KIT, TRUE METRIX METERMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZA4799S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/04/2022
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 12/06/2022
• Supplement Dates FDA Received: 01/03/2023
• 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): Other