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

Model Number	TRUEMETRIX
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Codes	Fatigue (1849); Blurred Vision (2137)
Date of Event	06/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Customer left the test strip vial open.Customer will get a new vial of strips.Test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.Unable to send product notification letter as no address on file.
Event or Problem Description
Consumer reported complaint for e-3 error: used test strip, test strip outside of vial too long, sample on top of test strip.The e-3 error occurred when the test strip was inserted into the truemetrix meter.At the time of the call, the customer reported feeling clammy and having blurry vision and low energy.Customer did not need medical attention at the time of the call.Customer was using proper testing technique.The product is not stored according to specification and is stored in the kitchen.The test strip lot manufacturer's expiration date is 08/31/2019 and open vial date was undisclosed.Test strips are stored in the original container.Three nights ago customer did leave the vial cap open for the whole night.Customer was advised to purchase new test strips.During the call on (b)(6) 2018, a blood test was not performed by the customer.
Additional Manufacturer Narrative
(manufacturer narrative: t, corrected data: t) internal report#: (b)(4).Product not returned for evaluation.No replacement product needed at this time.Customer left the test strip vial open.Customer will get a new vial of strips.Most likely underlying root cause: mlc-20-user's test strip had poor storage.Test strip udi#: (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call, unable to establish contact with the customer at this time.Unable to send product notification letter as no address on file.Correction: add an mlurc based on the information provided by customer on the initial call.
Event or Problem Description
Consumer reported complaint for e-3 error: used test strip, test strip outside of vial too long, sample on top of test strip.The e-3 error occurred when the test strip was inserted into the truemetrix meter.At the time of the call, the customer reported feeling clammy and having blurry vision and low energy.Customer did not need medical attention at the time of the call.Customer was using proper testing technique.The product is not stored according to specification and is stored in the kitchen.The test strip lot manufacturer's expiration date is 08/31/2019 and open vial date was undisclosed.Test strips are stored in the original container.Three nights ago customer did leave the vial cap open for the whole night.Customer was advised to purchase new test strips.During the call on (b)(6) 2018, a blood test was not performed by the customer.

• 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: 7715048
• Report Number: 1000113657-2018-00790
• Device Sequence Number: 1015809
• Product Code: NBW
• UDI-Device Identifier: 00096295126600
• UDI-Public: (01)00096295126600
• Combination Product (Y/N): N
• 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): 08/13/2018

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 Expiration Date: 08/31/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2816
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/13/2018
• 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