MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUETRACK; BLOOD GLUCOSE SYSTEM

Model Number	TRUETRACK
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Codes	Fatigue (1849); Tachycardia (2095)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause: mlc-56- user had an inaccurate reference: lab results: the end user is comparing results obtained from trividias's bgm system to the results from the laboratory test strip udi# (b)(4).Note: manufacturer contacted customer on 11/27/2018 in a follow-up call to ensure the customer's condition since the initial call: contact the pharmacy tech which states that the customer's condition has improved,the diagnosis/ treatment is still unknown.The customer has left the hospital but i could not get any more information from her.She will have the customer call us and let us know how he is doing since i do not have his phone number and she will provide our phone number to the customer to call us.
Event or Problem Description
Consumer reported complaint for low blood glucose test results accompanied by symptoms.Pharmacy tech is calling on behalf of the customer.The customer is concerned with tests results of 300 mg/dl.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of fatigue and rapid heart beat.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 12/31/2020 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Call transferred to me had to speak to the pharmacy at the hospital.On (b)(6) 2018 the customer was in his car and ran his blood since he was not feeling well.His heart was racing, and he went into the er.They ran his blood glucose test (did not know how much time passed from when he ran his blood) and it was 600 mg/dl vs 300 mg/dl.On his meter in the car.I was not speaking to the customer.The pharmacy tech did not have any information other than the meter was not reading correctly vs the hospital blood result.The customer might still be in the hospital.It's unknown how long he will be there since we do not know if there are any other problems with his health.I never had a chance to speak to the customer (only the tech in the pharmacy).It's unknown when the strips were opened, if the strips were stored correctly or if the blood results were fasting or non-fasting.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) sections with additional information as of 15-may-2020: h6: updated fda's method and conclusion codes.H10: retention testing was performed using test strips from the same lot.Retention strip lot tested and passed.Internal report #(b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause: mlc-56- user had an inaccurate reference: lab results: the end user is comparing results obtained from trividias's bgm system to the results from the laboratory.Test strip udi# (b)(4).Note: manufacturer contacted customer on 11/27/2018 in a follow-up call to ensure the customer's condition since the initial call: contact the pharmacy tech which states that the customer's condition has improved,the diagnosis/ treatment is still unknown.The customer has left the hospital but i could not get any more information from her.She will have the customer call us and let us know how he is doing sinc ei do not have his phone number and she will provide our phone number to the customer to call us.
Event or Problem Description
Consumer reported complaint for low blood glucose test results accompanied by symptoms.Pharmacy tech is calling on behalf of the customer.The customer is concerned with tests results of 300mg/dl.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of fatigue and rapid heart beat.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 12/31/2020 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Call transferred to me had to speak to the pharmacy at the hospital.On (b)(6) 2018 the customer was in his car and ran his blood since he was not feeling well.His heart was racing, and he went into the er.They ran his blood glucose test (did not know how much time passed from when he ran his blood) and it was 600mg/dl vs 300mg/dl.On his meter in the car.I was not speaking to the customer.The pharmacy tech did not have any information other than the meter was not reading correctly vs the hospital blood result.The customer might still be in the hospital.It's unknown how long he will be there since we do not know if there are any other problems with his health.I never had a chance to speak to the customer (only the tech in the pharmacy).It's unknown when the strips were opened, if the strips were stored correctly or if the blood results were fasting or non-fasting.

• Brand Name: TRUETRACK
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8174212
• Report Number: 1000113657-2018-01257
• Device Sequence Number: 16679857
• Product Code: NBW
• UDI-Device Identifier: 00087701866807
• UDI-Public: (01)00087701866807
• Combination Product (Y/N): N
• Initial Reporter State: OH
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2020

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 Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RV5280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY; SECOND THERAPY
• Outcome Attributed to Adverse Event: Hospitalization