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

Model Number	STRIP, RLN TMX 100CTMG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was returned for evaluation-no defect found.Test strips were not returned for evaluation.Most likely underlying root cause: mlc-020: use/storage-improper storage note: manufacturer contacted customer in several follow-up calls 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 high blood glucose test results.The customer is concerned with test results from results obtained of 142, 131 and 148 mg/dl.The customer¿s expected am fasting blood glucose test result range is 75-95 mg/dl.Customer stated that the truemetrixmeter was dropped and since then the results have been higher.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored according to specification (kitchen).The customer did have another vial of test strips.Same lot number, that had been stored and handled correctly.During the call, a back to back blood test was performed by the customer fasting and produced test results of 150 mg/dl and 147 mg/dl using truemetrix meter; customer was satisfied with the results obtained.The meter memory was reviewed for previous test result history: (b)(6).High blood customer calling concern with the results he has been getting for the past few days.Customer states that the meter is giving high blood results.Customer states that they increase his insulin to 24 units from 22 units 4days ago.Customer is taking his insulin at night and his normal glucose range is 75-95 mg/dl fasting am but now for the pas few days he have been getting high results(customer is only testing fasting am) customer states that the meter was dropped and since then the results are higher.I will send replacement, meter, strips and control solution.

• 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: 11561982
• Report Number: 1000113657-2021-00197
• Device Sequence Number: 11850202
• Product Code: NBW
• UDI-Device Identifier: 00021292012236
• UDI-Public: (01)00021292012236
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Device Model Number: STRIP, RLN TMX 100CTMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MX4321S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Distributor Facility Aware Date: 02/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1