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

Model Number	TRUEMETRIX
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	11/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is undergoing an evaluation but has not yet been completed test strip- (b)(4).Manufacturer contacted customer with follow up phone calls for knowing customer's conditions;customer is feeling fine at the time of the call;customer reported was hospitalized on (b)(6) 2016 due to the 600mg/dl high readings obtained;customer tested when arrived and obtained results of 800mg/dl;customer was treated with insulin;customer was prescribed with increase of insulin dosage;customer discharged on (b)(6) 2016;customer informed is comfortable with the new product replacement reading provided by pharmacy.
Event or Problem Description
Costumer reported complaint for high blood glucose test results of 600mg/dl.The customer is concerned with tests results from results obtained of 600mg/dl.The customer's expected fasting blood glucose test result range is 160-180mg/dl.The customer feels well and did not report any symptoms.Medical attention is reported as a result of the actual blood glucose results on (b)(6) 2016.The test strip lot manufacturer's expiration date is (b)(6) 2016 and open vial date is undisclosed.The meter memory was reviewed for previous test result history: (b)(6).Customer called in and left message stating meter was reading 600mg/dl and she was going to get meter replaced at local pharmacy.Called customer back, unable to establish contact with customer, left voicemail with contact information.Called local pharmacy to see if customer had picked up a new meter and strips.Pharmacist, (b)(6), stated customer did pick up new meter and strips and customer did leave a meter and a vial of strips.Obtained readings from memory through pharmacist who went through memory.Will send out replacement meter and strips to pharmacy and will also send prepaid envelope for pharmacy to return allegedly defective meter.
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips evaluated with defect found.Most likely underlying root cause is improper storage: strips left outside of the vial for an extended period of time.(b)(4).Manufacturer contacted customer with follow up phone calls for knowing customer's conditions;customer is feeling fine at the time of the call;customer reported was hospitalized on (b)(6) 2016 due to the 600mg/dl high readings obtained;customer tested when arrived and obtained results of 800mg/dl;customer was treated with insulin;customer was prescribed with increase of insulin dosage;customer discharged on (b)(6) 2016;customer informed is comfortable with the new product replacement reading provided by pharmacy.
Event or Problem Description
Costumer reported complaint for high blood glucose test results of 600mg/dl.The customer is concerned with tests results from results obtained of 600mg/dl.The customer's expected fasting blood glucose test result range is 160-180mg/dl.The customer feels well and did not report any symptoms.Medical attention is reported as a result of the actual blood glucose results on (b)(6) 2016.The test strip lot manufacturer's expiration date is 12/16/2016 and open vial date is undisclosed.The meter memory was reviewed for previous test result history: 1:600mg/dl (b)(6) 2016 12:00:00 pm fasting: no; 2: undisclosed; 3: undisclosed; 4: undisclosed; 5: undisclosed.Customer called in and left message stating meter was reading 600mg/dl and she was going to get meter replaced at local pharmacy.Called customer back, unable to establish contact with customer, left voicemail with contact information.Called local pharmacy to see if customer had picked up a new meter and strips.Pharmacist, (b)(6), stated customer did pick up new meter and strips and customer did leave a meter and a vial of strips.Obtained readings from memory through pharmacist who went through memory.Will send out replacement meter and strips to pharmacy and will also send prepaid envelope for pharmacy to return allegedly defective meter.

• Brand Name: TRUEMETRIX
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 6182919
• Report Number: 1000113657-2016-02045
• Device Sequence Number: 443748
• Product Code: NBW
• UDI-Device Identifier: 00087701426520
• UDI-Public: (01)00087701426520
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2016

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MS1472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2016
• Supplement Report FDA Received Date: 12/27/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization