VACU-TEC TUBES IN THE VES-MATIC ESR TESTING SYSTEM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-06-12 for VACU-TEC TUBES IN THE VES-MATIC ESR TESTING SYSTEM * manufactured by Diesse Diagnostica Senese Sri.

Event Text Entries

[226699] In 1/01, medical center started utilizingb a new product, vacu-tec tube in the ves-matic esr testing system for determining the sedimentation rates in pt population. A blood culture drawn from one of pts yielded ochrobactrum anthropi. It was determined from the pt's clinical condition and work-up that this organism was most likely a contaminant and the pt subsequently was not treated with antimicrobials. Since this first case an add'l 12 positives blood cultures have grown o. Anthropi with no clinical disease in the 12 pts. Two pts also grew s. Maltophilia from the same blood culture that grew o. Anthropi. Clinical review of pt medical records is ongoing. Further info will follow when completed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1022192
• MDR Report Key: 338408
• Date Received: 2001-06-12
• Date of Report: 2001-06-12
• Date of Event: 2001-01-16
• Date Added to Maude: 2001-06-25
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VACU-TEC TUBES IN THE VES-MATIC ESR TESTING SYSTEM
• Generic Name: ESR TESTING SYSTEM
• Product Code: GKB
• Date Received: 2001-06-12
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 327712
• Manufacturer: DIESSE DIAGNOSTICA SENESE SRI
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-06-12