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

Model Number	TRUETRACK
Medical Device Problem Codes	High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Hyperglycemia (1905); Weakness (2145)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with defect found.Test strips no returned for evaluation.Qc investigation on (b)(6) 2018 resulted in defect found; returned meter produce e-4 error code.Final root cause: rc-001-miscellaneous user induced contamination on the strip connector.Test strip udi# (b)(4).Note: follow-up call was made on (b)(6) 2018 in an effort to ensure the customers new replacement products have resolved the customer original concerns.Spoke with customer who states they have not used their replacement products, will give customer a call back.Manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for hi accompanied by symptoms.The expected fasting blood glucose test result range is 150-180mg/dl.The customer did report symptom of feeling very tired.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is not stored by customer according to specification in the kitchen.The test strip lot manufacturer's expiration date is 11/30/2020 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (date/time not stored correctly), result 1:560mg/dl date: (b)(6) 2018 time:12:18pm n/fasting, result 2:hi date: (b)(6) 2018 time:10:46am n/fasting, result 3:hi date: (b)(6) 2018 time:9:41am fasting, result 4:hi date: (b)(6) 2018 time:8:08am fasting, result 5:hi date: (b)(6) 2018 time:10:57pm n/fasting.A call back was made on (b)(6) 2018; customers condition has not improved since the time of the call.Customer did not take her lantus last night and woke up with a 452mg/dl fasting as her blood sugar and was not feeling well.Customer is still feeling exhausted and very weak.Customer did need to seek any medical intervention on (b)(6) 2018.Customer has been non-compliant with her regiment of medication and diet and therefore is getting very high results for her blood sugar.Nurse spoke with the doctor and the doctor recommended that she go to the hospital to seek medical attention.Customer was feeling exhausted and very weak and was treated for hyperglycemia 563mg/dl fasting.Customer was kept hydrated with water throughout and was also given injections of insulin.Upon being discharged on (b)(6) 2018 her blood sugar read 222mg/dl fasting.Any additional blood tests performed with the alleged defective device: yes, 452mg/dl fasting.Customer is currently not following her diet or medication routine and her blood sugar is not being regulated correctly.Customer leaved the hospital on (b)(6) 2018.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) sections with additional information as of 15-may-2020: h10: test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested and passed.Internal report # (b)(4).Returned meter evaluated with defect found.Test strips no returned for evaluation.Qc investigation on 10/16/2018 resulted in defect found; returned meter produce e-4 error code.Final root cause: rc-001-miscellaneous user induced contamination on the strip connector.Test strip udi# (b)(4).Note: follow-up call was made on 10/1/2018 in an effort to ensure the customers new replacement products have resolved the customer original concerns.Spoke with customer who states they have not used their replacement products, will give customer a call back.Manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for hi accompanied by symptoms.The expected fasting blood glucose test result range is 150-180mg/dl.The customer did report symptom of feeling very tired.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is not stored by customer according to specification in the kitchen.The test strip lot manufacturer's expiration date is 11/30/2020 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (date/time not stored correctly).Result 1:560mg/dl date:9/24/2018 time:12:18pm n/fasting.Result 2:hi, date: (b)(6) 2018, time:10:46am, n/fasting.Result 3:hi, date: (b)(6) 2018, time:9:41am, fasting.Result 4:hi, date: (b)(6) 2018, time:8:08am, fasting.Result 5:hi, date: (b)(6) 2018, time:10:57pm, n/fasting.A call back was made on 9/27/2018; customers condition has not improved since the time of the call.Customer did not take her lantus last night and woke up with a 452mg/dl fasting as her blood sugar and was not feeling well.Customer is still feeling exhausted and very weak.Customer did need to seek any medical intervention on (b)(6) 2018.Customer has been non-compliant with her regiment of medication and diet and therefore is getting very high results for her blood sugar.Nurse spoke with the doctor and the doctor recommended that she go to the hospital to seek medical attention.Customer was feeling exhausted and very weak and was treated for hyperglycemia 563mg/dl fasting.Customer was kept hydrated with water throughout and was also given injections of insulin.Upon being discharged on (b)(6) 2018 her blood sugar read 222mg/dl fasting.Any additional blood tests performed with the alleged defective device: yes, 452mg/dl fasting.Customer is currently not following her diet or medication routine and her blood sugar is not being regulated correctly.Customer leaved the hospital on (b)(6) 2018.

• 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: 7987268
• Report Number: 1000113657-2018-01084
• Device Sequence Number: 13811420
• Product Code: NBW
• UDI-Device Identifier: 00052569132463
• UDI-Public: (01)00052569132463
• Combination Product (Y/N): N
• Initial Reporter State: CT
• PMA/510(K) Number: K032657
• 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,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: RV5269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 10/19/2018
• 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