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	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 (several attempts) in a follow-up call 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.The customer is concerned with tests results from all the results obtained.The expected fasting blood glucose test result range is 90-100mg/dl.The customer did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification in the bathroom.During the call on (b)(6)2018, a blood test was not performed by the customer.The test strip lot manufacturer's expiration date is 08/31/2019 and open vial date is 5 days ago.The meter memory was reviewed for previous test result history.(b)(6).Customer states that her doctor put her on two new insulin.Customer run a back to back test and got 50-point different on the same hand same drop of blood.I review with customer about proper back to back testing and customer states that she in unable trust the meter.Customer states that some of her results are high blood and erratic customer normal glucose range is 90-100mg/dl fasting, and she test 2 times day.Strips are being stored in the bathroom.
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with tests results from all the results obtained.The expected fasting; blood glucose test result range is 90-100mg/dl, the customer did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification in the bathroom.During the call on 11/12/2018,, a blood test was not performed by the customer.The test strip lot manufacturer's expiration date is 08/31/2019 and open vial date is 5 days ago.The meter memory was reviewed for previous test result history.Result 1:155mg/dl, date:11/12/2018, time:852am, fasting; result 2:133mg/dl, date:11/12/2018, time852am, fasting; result 3:296 mg/dl, date:11/11/2018, time:206am, fasting; result 4:346mg/dl, date:11/11/2018, time:205am, fasting; result 5:164mg/dl, date:11/11/2018, time: 856pm, fasting.Customer states that her doctor put her on two new insulin.Customer run a back to back test and got 50point different on the sam, e hand sam,e drop of blood.I review with customer about proper back to back testing and customer states that she in unable trust the meter.Customer states that some of her results are high blood and erratic customer normal glucose range is 90-100mg/dl, fasting; and she test 2 times day.Strips are being stored in the bathroom.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4) returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause: mlc-20-user's test strip had poor storage(bathroom).Test strip udi#: (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call 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.

• 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: 8135457
• Report Number: 1000113657-2018-01218
• Device Sequence Number: 1686086
• Product Code: NBW
• UDI-Device Identifier: 00021292006051
• UDI-Public: (01)00021292006051
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 12/14/2018

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 Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2802S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 12/14/2018
• 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