MAUDE Adverse Event Report: INOVA DIAGNOSTICS, INC QUANTA FLASH H-TTG IGA; AUTOANTIBODIES, ENDOMYSIAL (TISSUE TRANSGLUTAMINASE

Lot Number 1059

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2017

Event Type  Injury  

Event Description

Several complaints have been received by the laboratory where the inova quanta flash human tissue transglutaminase iga testing did not fit the clinical picture or there were negative results by other reference laboratories.Dates of use: (b)(6) 2017.Diagnosis or reason for use: aid in the diagnosis of the gluten sensitive enteropathies.

• Brand Name: QUANTA FLASH H-TTG IGA
• Type of Device: AUTOANTIBODIES, ENDOMYSIAL (TISSUE TRANSGLUTAMINASE
• Manufacturer (Section D): INOVA DIAGNOSTICS, INC
• MDR Report Key: 6584659
• MDR Text Key: 75855402
• Report Number: MW5069924
• Device Sequence Number: 1
• Product Code: MVM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/01/2017
• Device Lot Number: 1059
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13 YR