MAUDE Adverse Event Report: LUMINEX MOLECULAR DIAGNOSTICS XTAG GASTROINTESTINAL PATHOGEN PANEL (XTAG GPP); GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED

Catalog Number I032C0415

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem No Information (3190)

Event Date 02/21/2014

Event Type  malfunction  

Event Description

We have been getting false positive results with our giardia test kits.

• Brand Name: XTAG GASTROINTESTINAL PATHOGEN PANEL (XTAG GPP)
• Type of Device: GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED
• Manufacturer (Section D): LUMINEX MOLECULAR DIAGNOSTICS; 12212 technology blvd.; austin TX 78727
• MDR Report Key: 3678877
• MDR Text Key: 19968547
• Report Number: 3678877
• Device Sequence Number: 2
• Product Code: PCH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/05/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: I032C0415
• Device Lot Number: IK032C-007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1