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

Model Number	TRUETRACK
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Codes	Weakness (2145); Sweating (2444)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause : mlc-37- code key connector issue.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 and if replacement products resolved the initial concern - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for "---"accompanied by symptoms.(b)(6) is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling weak and sweaty.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 01/18/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4).No test strips return for evaluation.Returned meter evaluated with defect found.Qc investigation on 7/11/2017 resulted in damaged/dirty code key connector.Bent pin on code key connector.Final root cause: bent pin on code key connector due to mechanical stress.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 and if replacement products resolved the initial concern - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for "---"accompanied by symptoms.Fred is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling weak and sweaty.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 01/18/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.

• Brand Name: TRUETRACK
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 6666920
• Report Number: 1000113657-2017-01087
• Device Sequence Number: 1972239
• Product Code: NBW
• UDI-Device Identifier: 00021292001971
• UDI-Public: (01)00021292001971
• Combination Product (Y/N): N
• Initial Reporter State: WI
• PMA/510(K) Number: K032657
• 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): 07/13/2017

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 Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 06/01/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1