ABL700 SERIES ABL720 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2006-07-11 for ABL700 SERIES ABL720 * manufactured by Radiometer Medical Aps.

Event Text Entries

[537367] When using an abl720 blood gas analyzer wrong ph-values were measured. The wrong values were caused by a clot in the ph measuring chamber. According to our internal guideline ve. Kva. 0029, all measurement errors because of clots are reportable.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3002807968-2006-00034
• MDR Report Key: 770137
• Report Source: 01
• Date Received: 2006-07-11
• Date of Event: 2006-06-13
• Date Mfgr Received: 2006-06-13
• Date Added to Maude: 2006-10-18
• 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: GERT NIELSEN
• Manufacturer Street: AKANDEVEJ 21
• Manufacturer City: BRONSHOJ DK-2700
• Manufacturer Country: DA
• Manufacturer Postal: DK-2700
• Manufacturer Phone: 8273057
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ABL700 SERIES
• Generic Name: ABL700
• Product Code: CCE
• Date Received: 2006-07-11
• Model Number: ABL720
• Catalog Number: *
• 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: 757965
• Manufacturer: RADIOMETER MEDICAL APS
• Manufacturer Address: AKANDEVEJ 21 BRONSHOJ DA DK-2700

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-07-11