ORTHO PROVUE ANALYZER MTS213784

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-05-25 for ORTHO PROVUE ANALYZER MTS213784 manufactured by Micro Typing Systems, Inc..

Event Text Entries

[471841] The customer reported that they observed leaking from the probe area of the ortho provue analyzer.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1056600-2006-00074
• MDR Report Key: 721307
• Report Source: 06
• Date Received: 2006-05-25
• Date of Report: 2006-05-24
• Date of Event: 2006-04-24
• Date Mfgr Received: 2006-04-24
• Device Manufacturer Date: 2005-11-01
• Date Added to Maude: 2006-06-02
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 0
• Manufacturer Contact: DAVID HAGEN, SITE MANAGER
• Manufacturer Street: 1295 SW 29TH AVENUE
• Manufacturer City: POMPANO BEACH FL 33069
• Manufacturer Country: US
• Manufacturer Postal: 33069
• Manufacturer Phone: 9546239528
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: RP
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ORTHO PROVUE ANALYZER
• Generic Name: AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM
• Product Code: KZS
• Date Received: 2006-05-25
• Model Number: MTS213784
• Catalog Number: ORTHO PROVUE
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 710377
• Manufacturer: MICRO TYPING SYSTEMS, INC.
• Manufacturer Address: 1295 S.W. 29TH AVENUE POMPANO BEACH FL 33069 US
• Baseline Brand Name: ORTHO PROVUE ANALYZER
• Baseline Generic Name: AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM
• Baseline Model No: MTS213784
• Baseline Catalog No: ORTHO PROVUE
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2006-05-25