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

Model Number	STRIP, LEADER TT MEDIMEDI 50CT
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Test strips were not returned for evaluation.Meter was returned- product evaluation in-process.Note: manufacturer contacted customer in a follow-up call on 17-mar-2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.Granddaughter is calling on behalf of the customer.The customer is concerned with test results from results obtained of 64 mg/dl.The customer¿s expected am fasting blood glucose test result is 125 mg/dl and expected pm fasting blood glucose test result range is 170-200 mg/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.During the call, a back to back blood test was performed by the customer pm fasting and produced test results of 234 mg/dl and 271 mg/dl using true track meter; the customer was not satisfied with the results obtained.The product is stored according to specification in the living room.The test strip lot manufacturer¿s expiration date is 12/17/2022 and test strips were opened two days prior to call.The meter memory was reviewed for previous test result history (date not set): (b)(6).
Additional Manufacturer Narrative
Sections with additional information as of 26-apr-2022: h6: updated fda¿s type, findings and conclusions 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 within specifications.
Additional Manufacturer Narrative
Sections with additional information as of 06-jun-2022: h3: was the device evaluated by the manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: test strips were not returned for evaluation.Meter was returned for evaluation.Product testing was performed and no defect found.Most likely underlying root cause: mlc-062: user had poor technique.Corrected sections as of 06-jun-2022: h10: "meter was not returned for evaluation" to "meter was returned for evaluation".

• Brand Name: TRUETRACK
• 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: 13995047
• Report Number: 1000113657-2022-00190
• Device Sequence Number: 14717079
• Product Code: NBW
• UDI-Device Identifier: 00021292008642
• UDI-Public: (01)00021292008642
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2022

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: 12/17/2022
• Device Model Number: STRIP, LEADER TT MEDIMEDI 50CT
• Device Catalogue Number: A4H01-81
• Device Lot Number: RX5411S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/08/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 05/10/2022; 05/10/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 04/26/2022; 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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