XTAG GASTROINTESTINAL PATHOGEN PANEL (XTAG GPP) * I032C0415

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-06 for XTAG GASTROINTESTINAL PATHOGEN PANEL (XTAG GPP) * I032C0415 manufactured by Luminex Molecular Diagnostics.

Event Text Entries

[19968547] We have been getting false positive results with our giardia test kits.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3678877
• MDR Report Key: 3678877
• Date Received: 2014-03-06
• Date of Report: 2014-03-05
• Date of Event: 2014-02-21
• Report Date: 2014-03-05
• Date Reported to FDA: 2014-03-06
• Date Reported to Mfgr: 2014-03-14
• Date Added to Maude: 2014-03-14
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: XTAG GASTROINTESTINAL PATHOGEN PANEL (XTAG GPP)
• Generic Name: GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED
• Product Code: PCH
• Date Received: 2014-03-06
• Model Number: *
• Catalog Number: I032C0415
• Lot Number: IK032C-005
• ID Number: *
• Operator: OTHER
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: LUMINEX MOLECULAR DIAGNOSTICS
• Manufacturer Address: 12212 TECHNOLOGY BLVD. AUSTIN TX 78727 US 78727

Device Sequence Number: 2

• Brand Name: XTAG GASTROINTESTINAL PATHOGEN PANEL (XTAG GPP)
• Generic Name: GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED
• Product Code: PCH
• Date Received: 2014-03-06
• Model Number: *
• Catalog Number: I032C0415
• Lot Number: IK032C-007
• ID Number: *
• Device Availability: N
• Device Age: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: LUMINEX MOLECULAR DIAGNOSTICS
• Manufacturer Address: 12212 TECHNOLOGY BLVD. AUSTIN TX 78727 US 78727

Device Sequence Number: 3

• Brand Name: XTAG GASTROINTESTINAL PATHOGEN PANEL (XTAG GPP)
• Generic Name: GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED
• Product Code: PCH
• Date Received: 2014-03-06
• Model Number: *
• Catalog Number: I032C0415
• Lot Number: IK032C-008
• ID Number: *
• Device Availability: N
• Device Age: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: LUMINEX MOLECULAR DIAGNOSTICS
• Manufacturer Address: 12212 TECHNOLOGY BLVD. AUSTIN, TX 78727 US 78727

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-03-06