ABBOTT IMX SYSTEM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-04-09 for ABBOTT IMX SYSTEM * manufactured by Abbott Laboratories.

Event Text Entries

[18969392] Hepatitis a antibody igm laboratory test was positive. Pt was asymptomatic and reported previous hepatitis a infection.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1031812
• MDR Report Key: 522388
• Date Received: 2004-04-09
• Date of Report: 2004-04-09
• Date of Event: 2004-01-07
• Date Added to Maude: 2004-04-29
• 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: 3
• 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 Sequence Number: 1

• Brand Name: ABBOTT IMX SYSTEM
• Generic Name: AUTOMATED ANALYZER TO DETECT HEPATITIS
• Product Code: LOL
• Date Received: 2004-04-09
• Model Number: *
• Catalog Number: *
• Lot Number: 10769Q100
• ID Number: *
• Device Expiration Date: 2004-06-18
• Operator: OTHER
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 511516
• Manufacturer: ABBOTT LABORATORIES
• Manufacturer Address: * ABBOTT PARK IL 60064 US

Device Sequence Number: 2

• Brand Name: ABBOTT IMX SYSTEM
• Generic Name: AUTOMATED ANALYZER TO DETECT HEPATITIS
• Product Code: IMX
• Date Received: 2004-04-09
• Model Number: *
• Catalog Number: *
• Lot Number: 10762Q100
• ID Number: *
• Device Expiration Date: 2004-06-18
• Operator: OTHER
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 511682
• Manufacturer: ABBOTT LABS
• Manufacturer Address: * ABBOTT PARK IL 60064 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-04-09