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

Model Number	STRIP, PRO TMX HSC 50CTMG/DL
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Adverse event report is being submitted due to customer contacting doctor due to meter results.Meter and test strips were returned for evaluation.Product testing was performed and no defect found.Most likely underlying root cause: mlc-069: using incorrect test strip platform.Note: manufacturer contacted customer in a follow-up call on 19-apr-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.Daughter stated that since the last call, customer had contacted his doctor and had a telephone consult due his concern with the results obtained.The doctor had increased the customer's insulin (it was not disclosed by how much).
Event or Problem Description
Consumer reported complaint for erratic blood glucose test results.Daughter is calling on behalf of the customer.The customer is concerned with test results from back to back blood tests of 279 and 298 mg/dl.Customer was also concerned with results obtained of 339 and 285 mg/dl; tests were not performed back to back.Customer was using the incorrect test strips with the true metrix meter; customer was using true metrix pro test strips.The customer did not know his expected blood glucose test result range.The customer feels well and did not report any symptoms.At the time of the initial call, medical attention was not reported as a result of the actual blood glucose results.During the call, a back to back blood test was not performed by the customer.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 03/31/2022 and open vial date is 04/05/2021.The meter memory was reviewed for previous test result history: (b)(6).

• 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
• MDR Report Key: 11826796
• Report Number: 1000113657-2021-00314
• Device Sequence Number: 3436719
• Product Code: NBW
• UDI-Device Identifier: 00021292007867
• UDI-Public: (01)00021292007867
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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: 03/31/2022
• Device Model Number: STRIP, PRO TMX HSC 50CTMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZX4093S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Distributor Facility Aware Date: 04/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/14/2021
• 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: Required Intervention