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

Model Number	TRUEMETRIX
Medical Device Problem Codes	Incorrect Or Inadequate Test Results (2456); High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is undergoing an evaluation but has not yet been completed.(b)(4).
Event or Problem Description
Consumer reported complaint for erratic blood glucose test results.The customer stated that the meter was also giving high readings.The customer is concerned with tests results from back to back blood tests using truemetrix meter of 197 and 234 mg/dl.The customer's expected fasting blood glucose test result range is 120 - 130 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 on (b)(6) 2016, a back to back blood test was not performed by the customer.The product is not stored according to specification and is stored in the kitchen.The test strip lot manufacturer's expiration date is 09/30/2017 and open vial date at time of call is about a month ago.The meter memory was reviewed for previous test result history: (b)(6).Memory concerns: 197 234 162 161 191mg/dl customer is calling concerned that his meter is giving both erratic and high readings.Customer did a back to back fasting test on the same hands, different fingers and obtained a 234mg/dl then a 197mg/dl.
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with defect found - meter not operational (dead).Test strips evaluated with no defect found.Root cause: bent positive battery tab.(b)(4).
Event or Problem Description
Consumer reported complaint for erratic blood glucose test results.The customer stated that the meter was also giving high readings.The customer is concerned with tests results from back to back blood tests using truemetrix meter of 197 and 234 mg/dl.The customer's expected fasting blood glucose test result range is 120 - 130 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 on (b)(6) 2016, a back to back blood test was not performed by the customer.The product is not stored according to specification and is stored in the kitchen.The test strip lot manufacturer's expiration date is 09/30/2017 and open vial date at time of call is about a month ago.The meter memory was reviewed for previous test result history: 197mg/dl (b)(6) 2016 10:34 pm fasting: yes, 234mg/dl (b)(6) 2016 10:33 pm fasting: yes, 162mg/dl (b)(6) 2016 10:40 pm fasting: yes, 161mg/dl (b)(6) 2016 01:05 am fasting: yes, 191mg/dl (b)(6) 2016 10:46 am fasting: yes.Memory concerns: 197 234 162 161 191mg/dl customer is calling concerned that his meter is giving both erratic and high readings.Customer did a back to back fasting test on the same hands, different fingers and obtained a 234mg/dl then a 197mg/dl.

• 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: 6266682
• Report Number: 1000113657-2017-00105
• Device Sequence Number: 889285
• Product Code: NBW
• UDI-Device Identifier: 00010939722447
• UDI-Public: (01)00010939722447
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2017

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: 09/30/2017
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT1706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2017
• Supplement Report FDA Received Date: 02/09/2017
• 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