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

Model Number	STRIP, PRO TMX HSC 50CTMG/DL
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Fatigue (1849); Nausea (1970); Dizziness (2194)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was not returned for evaluation.Test strips were returned for evaluation.Qc evaluation pending.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.Product notification letter sent to contact customer care.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.Product notification letter sent to contact customer care.
Event or Problem Description
Consumer reported complaint for e-5 error code.Nurse is calling on behalf of facility.The e-5 error occurred as soon as the blood sample was absorbed.At the time the e-5 error was obtained, nurse stated the patient had reported symptoms of nausea, dizziness and fatigue.Nurse stated that prior to her calling, the patient's son had stated he was taking patient to the emergency room.Patient was not available at time of call.Proper testing technique was not being used.The product is stored according to specification in the laboratory in the facility.The test strip lot manufacturer¿s expiration date is 12/31/2020 and open vial date is (b)(6) 2019.
Additional Manufacturer Narrative
Sections with additional information as of 19-feb-2020: h10: meter was not returned for evaluation.Test strips were returned for evaluation; no defect was detected.Control solution was returned for evaluation; no defect was detected.

• Brand Name: TRUE METRIX PRO
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 9623316
• Report Number: 1000113657-2020-00050
• Device Sequence Number: 14184888
• Product Code: NBW
• UDI-Device Identifier: 00021292007867
• UDI-Public: (01)00021292007867
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: STRIP, PRO TMX HSC 50CTMG/DL
• Device Catalogue Number: RE4H01P-43
• Device Lot Number: MW3394S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Distributor Facility Aware Date: 12/27/2019
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1