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

Model Number	STRIP, RH TMX SUPPLY KIT10CT MG/DL 24/CS
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Codes	Vomiting (2144); Dizziness (2194)
Date of Event	10/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Meter and test strips were not returned for evaluation.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.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.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.The customer is concerned with tests results from results obtained of 50 and 51mg/dl.The expected fasting blood glucose test result range is 100-150mg/dl.The customer did report symptoms of vomiting and dizziness.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is stored according to specification in the bedroom.During the call a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 01/31/2021 and open vial date is 4 days ago.The meter memory was reviewed for previous test result history.(b)(6).
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Sections with additional information as of 11-may-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.Corrected sections as of 11-may-2020: h1: type of reportable event corrected from "malfunction" to "serious injury".H3: device was returned to manufacturer for evaluation corrected from "yes" to "no".

• Brand Name: TRUE METRIX AIR
• 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: 9292435
• Report Number: 1000113657-2019-10132
• Device Sequence Number: 2362434
• Product Code: NBW
• UDI-Device Identifier: 00021292007843
• UDI-Public: (01)00021292007843
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K150052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Model Number: STRIP, RH TMX SUPPLY KIT10CT MG/DL 24/CS
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MW3451S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/14/2019
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization