GN 09

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-18 for GN 09 manufactured by Biomerieux.

Event Text Entries

[17770665] We perform microbiological cultures and sensitivities as part of routing clinical testing. Antibiotic sensitives are performed on biomerieux vitek ii. We sent a specimen positive for shigella sonnei -group d- to our state board of health lab for epidemiological monitoring. They regularly re-test the isolates for identification and sensitivity. We reported the sample as sensitive to bactrim, which is the most common result for this organism. Their sensitivity results did not match ours. Their test was performed on another instrument platform. It will be difficult to determine if previous lots of these cards are involved because we won't be able to re-test those isolates. Dates of use: twenty three days in 2007. Diagnosis or reason for use: isolate positive for shigella sonnei, sensitivity testing.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5001916
• MDR Report Key: 854949
• Date Received: 2007-05-18
• Date of Report: 2007-05-18
• Date of Event: 2007-05-17
• Date Added to Maude: 2007-06-25
• 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: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: GN 09
• Generic Name: VITEK II
• Product Code: LTW
• Date Received: 2007-05-18
• Lot Number: 106067210
• Device Expiration Date: 2007-10-16
• Device Availability: Y
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 850017
• Manufacturer: BIOMERIEUX

Device Sequence Number: 2

• Brand Name: GN 13
• Generic Name: VITEK II
• Product Code: LTW
• Date Received: 2007-05-18
• Device Availability: Y
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 2
• Device Event Key: 850018

Device Sequence Number: 3

• Brand Name: GN 17
• Generic Name: VITEK II
• Product Code: LTW
• Date Received: 2007-05-18
• Device Availability: Y
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 3
• Device Event Key: 850019

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2007-05-18