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	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip udi# (b)(4).Manufacturer contacted customer on (b)(4) 2018 in a follow up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with results obtained of 207 mg/dl.The expected fasting blood glucose test result range is 104 to 132 mg/dl.The customer feels well and did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored by customer according to specification in the bathroom.The test strip lot manufacturer's expiration date is 03/28/2020 and open vial date is one month ago.The meter memory was reviewed for previous test result history: (date/time not stored correctly), result 1 :101mg/dl, date: (b)(6) 2018, time:10:08am fasting; result 2: 207mg/dl, date: (b)(6) 2018, time:12:47pm fasting; result 3 :119mg/dl, date: (b)(6) 2018, time:4:10pm fasting; result 4 :111mg/dl, date: (b)(6) 2018, time:10:19am fasting; result 5 :147mg/dl, date: (b)(6) 2018, time: 7:09pm n/fasting.Customer called in and states the meter gave her 1 high reading during a back to back test.Customer is concerned that 207 mg/dl fasting is too high for her.Customer is storing test strips incorrectly and advised of proper storage technique.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = t) internal report # (b)(4) product not yet returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage(bathroom).Test strip udi#: (b)(4).Note: manufacturer contacted customer on 10/29/2018 in a follow up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.Correction: correction made on section h reflecting the wrong storage by user.Update the mlurc and evaluation codes.
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with results obtained of 207mg/dl.The expected fasting blood glucose test result range is 104 to 132mg/dl.The customer feels well and did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored by customer according to specification in the bathroom.The test strip lot manufacturer's expiration date is 03/28/2020 and open vial date is one month ago.The meter memory was reviewed for previous test result history: (date/time not stored correctly) result 1 :101mg/dl, date: (b)(6) 2018, time:10:08am, fasting; result 2 :207mg/dl, date: (b)(6) 2018, time:12:47pm, fasting; result 3 :119mg/dl, date: (b)(6) 2018, time:4:10pm, fasting; result 4 :111mg/dl, date: (b)(6) 2018, time:10:19am, fasting; result 5 :147mg/dl, date: (b)(6) 2018, time:7:09pm, n/fasting.Customer called in and states the meter gave her 1 high reading during a back to back test.Customer is concerned that 207mg/dl fasting is too high for her.Customer is storing test strips incorrectly and advised of proper storage technique.

• 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: 8032460
• Report Number: 1000113657-2018-01124
• Device Sequence Number: 1379541
• Product Code: NBW
• UDI-Device Identifier: 00021292006082
• UDI-Public: (01)00021292006082
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K140100
• 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): 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: MV2942
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 11/02/2018
• 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