inforMED
MalfunctionCCI

ANTEK NITROGEN ANALYZER

Received Jul 21, 1997 · Event occurred Jul 7, 1997

Report 1641354-1997-00001 · MDR key 108067

Device

Generic name

Class I In Vitro Diagnostic Device

Catalog number

99042 AND 99044

Lot number

1987

Patient

*

Narrative

Description of Event or Problem

USER REPORTED THAT RESPONSE WAS TOO LOW FOR KNOWN CONCENTRATION OF NITROGEN. THE PROBLEM WAS TURNED OVER TO THE BIOMEDICAL (MAINTENANCE) GROUP FOR THE UNIVERSITY.

Remedial action

  • Other