ISOLATOR 10 MICROBIAL BLOOD CULTURE TUBE * 50C7

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-11-15 for ISOLATOR 10 MICROBIAL BLOOD CULTURE TUBE * 50C7 manufactured by Iverness Medical Professional Diagnostics.

Event Text Entries

[547436] It takes an extra 1-2 days for the organisms to grow out, since the unlysed (whole blood) specimen just sits on top of the chocolate agar media plate. Normally the lysed blood cells absorb into the media. Microbiology supervisor suspects the lysing agent in the tubes is inactive or corrupt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 787477
• MDR Report Key: 787477
• Date Received: 2006-11-15
• Date of Report: 2006-11-15
• Date of Event: 2006-10-25
• Report Date: 2006-11-15
• Date Reported to FDA: 2006-11-15
• Date Added to Maude: 2006-11-29
• 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: 0
• Reporter Occupation: RISK MANAGER
• 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: ISOLATOR 10 MICROBIAL BLOOD CULTURE TUBE
• Generic Name: TUBE, BLOOD CULTURE
• Product Code: JSC
• Date Received: 2006-11-15
• Returned To Mfg: 2006-10-28
• Model Number: *
• Catalog Number: 50C7
• Lot Number: 609215
• ID Number: *
• Device Availability: R
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 775245
• Manufacturer: IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS
• Manufacturer Address: 2 RESEARCH WAY PRINCETON NJ 08540 US

Device Sequence Number: 2

• Brand Name: ISOLATOR 10 MICROBIAL BLOOD CULTURE TUBE
• Generic Name: TUBE, BLOOD CULTURE
• Product Code: JSC
• Date Received: 2006-11-15
• Model Number: *
• Catalog Number: 50C7
• Lot Number: 609111
• ID Number: *
• Device Availability: R
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 775246
• Manufacturer: IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS
• Manufacturer Address: 2 RESEARCH WAY PRINCETON NJ 08540 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-11-15