Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUEMETRIX; BLOOD GLUCOSE SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TRIVIDIA HEALTH, INC. TRUEMETRIX; BLOOD GLUCOSE SYSTEM Back to Search Results
Model Number TRUEMETRIX
Medical Device Problem Code High Test Results (2457)
Health Effect - Clinical Codes Nausea (1970); Weakness (2145)
Date of Event 07/09/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).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 high blood glucose test results.At the time of the call the customer reported feeling weak and nauseous.Customer stated she would seek medical attention.Customer did not proved expected blood glucose test result range or results of concern.The meter memory was not reviewed for previous test result history.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7747895
Report Number1000113657-2018-00824
Device Sequence Number1319676
Product Code NBW
UDI-Device Identifier00021292007256
UDI-Public(01)00021292007256
Combination Product (Y/N)N
PMA/510(K) Number
K140100
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date (Section B) 08/03/2018
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 Date05/31/2019
Device Model NumberTRUEMETRIX
Device Catalogue NumberRE4H01-81
Device Lot NumberMU2701
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 07/09/2018
Initial Report FDA Received Date08/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-