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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUETRACK; BLOOD GLUCOSE SYSTEM
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TRIVIDIA HEALTH, INC. TRUETRACK; BLOOD GLUCOSE SYSTEM Back to Search Results
Model Number TRUETRACK
Medical Device Problem Code High Test Results (2457)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/05/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation yet.Most likely underlying root cause of malfunction:user's test strips had a poor storage(kitchen).(b)(4).
 
Event or Problem Description
Costumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 393 mg/dl.The customer's expected fasting blood glucose test result range is 80 to 110 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.The test strip lot manufacturer's expiration date 10/31/2018 and open vial date is (b)(6) 2016.The meter memory was reviewed for previous test result history (date / time not set correctly): (b)(6).
 
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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 Key6132918
Report Number1000113657-2016-01923
Device Sequence Number11031855
Product Code NBW
UDI-Device Identifier00052569132463
UDI-Public(01)00052569132463
Combination Product (Y/N)N
Initial Reporter StateTN
PMA/510(K) Number
K032657
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Remedial Action Replace
Type of Report Initial
Report Date (Section B) 11/29/2016
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 NumberTRUETRACK
Device Catalogue NumberA4H01-81
Device Lot NumberRT4913
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location Home
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/05/2016
Initial Report FDA Received Date11/29/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
SECOND THERAPY
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