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

Model Number	STRIP, RH TMX SUPPLY KIT10CT MG/DL 24/CS
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	Muscle Weakness/Atrophy (1967)
Date of Event	02/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Adverse event report is being submitted due to symptoms related to diabetes: weakness.Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for error message (e-3).Wife is calling on behalf of the customer.At the time of the call the customer reported feeling weak; medical attention was not needed at the time.Customer was not using the proper testing technique.During the call, a blood test was performed by the customer fasting and produced test result of 68 mg/dl using true metrix meter.The customer does not know his expected blood glucose test result range; customer stated this is the first time he is performing a blood test.Customer stated that he has not eaten yet; customer stated he will eat and then perform another blood test.The product is stored according to specification; location was not disclosed but customer stated they are stored at room temperature.The test strip lot manufacturer¿s expiration date is 04/30/2023 and open vial date is (b)(6) 2022.
Additional Manufacturer Narrative
Sections with additional information as of 19-apr-2022: h6: updated fda¿s type, findings and conclusions 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 passed within specifications.Most likely underlying root cause: mlc-030: user applied blood to strip before inserting strip into meter.Corrected sections as of 19-apr-2022: h1: type of reportable event corrected from "malfunction" to "serious injury" due to symptoms.

• Brand Name: TRUE METRIX
• Common Device Name: 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: 13651929
• Report Number: 1000113657-2022-00113
• Device Sequence Number: 5750181
• Product Code: NBW
• UDI-Device Identifier: 00021292007843
• UDI-Public: (01)00021292007843
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Model Number: STRIP, RH TMX SUPPLY KIT10CT MG/DL 24/CS
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZY4526S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/03/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown