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

Model Number	METER, AIR TVH TMX NFRSMG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Headache (1880); Hyperglycemia (1905); Sweating (2444); Lethargy (2560)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Products were returned and pending qc evaluation.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2020 to ensure that the customer's condition improved - able to establish contact with customer and stated customer felt lethargic and still had a headache.Customer did not need any medical attention.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2020 to ensure that the customer's condition improved - able to establish contact with customer and stated customer was admitted to the hospital on (b)(6) 2020.Husband stated that his wife¿s blood sugar result was 518 mg/dl (did not disclose fasting/non-fasting) at 11 pm.The customer was diagnosed with hyperglycemia was still in the hospital.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2020 to ensure that the customer's condition improved - able to establish contact with customer's husband and stated his wife was discharged on (b)(6) 2020.Customer was receiving another call and is unable to provide any additional information.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2020 to ensure that the customer's condition improved - able to establish contact with customer and stated that is still not feeling well.Customer husband then came on the phone and states that he is busy getting groceries in the house and he had to go.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2020 to ensure that the customer's condition improved - able to establish contact with customer's husband and states that his wife is currently with a speech therapist.Customer's blood sugar was not the issues, at this the meter is working fine.Customer's husband stated she has visited different doctors but it is not due to diabetes.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2020 to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.
Event or Problem Description
Consumer reported complaint for meter does not turn on with strip inserted accompanied by symptoms.Husband is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of sweating and headache.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 10/31/2021 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Sections with additional information as of 20-aug-2020: h6: updated fda's method, result, and conclusion codes.H10: meter was returned for evaluation; no defect was detected.Test strips were returned for evaluation; defect detected: does not turn on with strip inserted.H10: most likely underlying root cause: rc-065: horizontal scratches crossing the electrodes.

• 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: 10323359
• Report Number: 1000113657-2020-00511
• Device Sequence Number: 515743
• Product Code: NBW
• UDI-Device Identifier: 00021292007447
• UDI-Public: (01)00021292007447
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/20/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Model Number: METER, AIR TVH TMX NFRSMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: ZX4008S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Distributor Facility Aware Date: 07/07/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/20/2020
• 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