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

Model Number	TRUETRACK
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure that the replacement products resolved the initial concern - 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 high blood glucose results.Daughter is calling on behalf of the customer.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 110 to 125 mg/dl.The customer feels well and did not report symptoms.Medical attention is reported as a result of the actual blood glucose.The product is stored by customer according to specification in the dining room.During the call on (b)(6) 2018, a back to back blood test was not performed.The test strip lot manufacturer's expiration date is 01/31/2020 and open vial date is unknown.The meter memory was reviewed for previous test result history: (date/time not stored correctly) (b)(6).Customer testing and results was in the 500's mg/dl (asymptomatic).The daughter gave her father insulin based on sliding scale.Customer tested again and blood sugar was still high.The daughter took father to the hospital where his blood sugar result was 338 mg/dl n/fasting - after insulin.Customer stayed at the hospital overnight for monitoring and discharge (on (b)(6) 2018) result was 267 mg/dl with hospital meter.Customer continued to use true track meter at home after discharge and readings were still high.Customer is not experiencing any symptoms now.Customer expected range is 110-120 mg/dl.
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure that the replacement products resolved the initial concern - 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 high blood glucose results.Daughter is calling on behalf of the customer.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 110 to 125mg/dl.The customer feels well and did not report symptoms.Medical attention is reported as a result of the actual blood glucose.The product is stored by customer according to specification in the dining room.During the call on 03/19/2018, a back to back blood test was not performed.The test strip lot manufacturer's expiration date is 01/31/2020 and open vial date is unknown.The meter memory was reviewed for previous test result history: (date/time not stored correctly) result 1:364mg/dl date:3/19 time:221p fasting.Result 2:237mg/dl date:3/19 time:1106a fasting.Result 3:500mg/dl date:3/19 time:231a fasting.Result 4:488mg/dl date:3/19 time:217a fasting.Result 5:591mg/dl date:3/19 time:203a fasting.Customer testing and results was in the 500's mg/dl (asymptomatic).The daughter gave her father insulin based on sliding scale.Customer tested again and blood sugar was still high.The daughter took fathert to the hospital where his blood sugar result was 338mg/dl n/fasting - after insulin.Customer stayed at the hospital overnight for monitoring and discharge on (b)(6) 2018 result was 267mg/dl with hospital meter.Customer continued to use true track meter at home after discharge and readings were still high.Customer is not experiencing any symptoms now.Customer expected range is 110-120mg/dl.

• 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: 7412283
• Report Number: 1000113657-2018-00422
• Device Sequence Number: 13846815
• Product Code: NBW
• UDI-Device Identifier: 00010939755339
• UDI-Public: (01)00010939755339
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/18/2018

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: RU5149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 04/18/2018
• 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