MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUEMETRIX; BLOOD GLUCOSE SYSTEM

Model Number TRUEMETRIX

Device Problem Low Test Results (2458)

Patient Problem Hyperglycemia (1905)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product not returned for evaluation.Unable to contact customer to replaced the product.Most likely underlying root cause: mlc-28-there was not enough information to determine the mlurc.Several attempts were made in an effort to get the trouble shoot the meter and get additional information regarding customer complaints.Unable to contact the customer with the phone # that was left on the voicemail ((b)(6)).I attempted to used the phone number several times and got message stating (the party you are calling is not available).We attempted to use another phone number from a previous ran ((b)(6)) but still unable to contact the customer and no voicemail was available to leave a message.

Event Description

Consumer reported complaint for low blood glucose results via acd message.The expected fasting blood glucose test result range is undisclosed.The customer did not report symptoms.Medical attention is reported as a result of the actual blood glucose results.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is undisclosed and open vial date is also undisclosed.The meter memory not reviewed for previous test result history.Due to the meter reading low, customer ended up in the hospital, at the hospital her reading was in the 900 `s.No further information is available.Unable to reach customer after several follow up attempts to obtain more information about the event.

• Brand Name: TRUEMETRIX
• Type of Device: BLOOD GLUCOSE SYSTEM
• 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 ; 954677-920
• MDR Report Key: 7155051
• MDR Text Key: 96225830
• Report Number: 1000113657-2017-02126
• Device Sequence Number: 1
• Product Code: NBW
• 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
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 12/06/2017
• 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