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

Model Number	STRIP, RH TMX SUPPLY KIT10CT MG/DL 24/CS
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 230, 155, 177 and 250mg/dl.The customer¿s expected am fasting blood glucose test result range is 80-120mg/dl and expected pm fasting blood glucose test result range is 120-150mg/dl.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 test strip lot manufacturer¿s expiration date is 06/30/2023 and open vial date is was not disclosed.The product is not stored according to specification (kitchen).The customer did have another vial of test strips that had been stored and handled correctly.During the call, a back to back blood test was performed by the customer non-fasting and produced test results of 176mg/dl and 185mg/dl using true metrix meter.The meter memory was reviewed for previous test result history (date not set): result 1: 148 mg/dl date:(b)(6) 2020 time: 536pm non-fasting (test taken today), result 2: 230 mg/dl date:(b)(6) 2022 time: 519pm fasting pm, result 3: 155 mg/dl date:(b)(6) 2022 time: 851am fasting am, result 4: 177 mg/dl date:(b)(6) 2022 time: 455am (does not remember this result), result 5: 250 mg/dl date:(b)(6) 2022 time: 751am fasting pm.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was returned for evaluation.Product testing was performed and no defect found.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot passed within specifications.Most likely underlying root cause: mlc-020: user's test strip had poor storage.Note: manufacturer contacted customer in a follow-up call on 31-mar-2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

• 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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 14190540
• Report Number: 1000113657-2022-00236
• Device Sequence Number: 20278452
• Product Code: NBW
• UDI-Device Identifier: 00021292007843
• UDI-Public: (01)00021292007843
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/22/2022

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: 06/30/2023
• Device Model Number: STRIP, RH TMX SUPPLY KIT10CT MG/DL 24/CS
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZY4612S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Distributor Facility Aware Date: 03/28/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown