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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-01-31 for * manufactured by Akers Biotech.

Event Text Entries

[453161] This device was purchased to be used in measuring lithium levels in the blood and hence its clearance by the kidneys. During use it was found that it gave inaccurately higher result than normal especially when used in high altitude and when the complaint was lodged with the co it was a suprise. Besides the more the red blood cells the less the amount of lithium that separates. The replacement has been sent.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1037838
• MDR Report Key: 680020
• Date Received: 2006-01-31
• Date of Report: 2006-01-31
• Date of Event: 2006-01-01
• Date Added to Maude: 2006-03-02
• 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 Details

• Brand Name: *
• Generic Name: INSTAREAD LITHIUM
• Product Code: JIH
• Date Received: 2006-01-31
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Expiration Date: 2006-08-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 669288
• Manufacturer: AKERS BIOTECH
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-01-31