inforMED
InjuryCGL

CREATININE PLUS SYSTEM PACK

Received Sep 8, 1997 · Event occurred Jul 26, 1997

Report 1823260-1997-00075 · MDR key 118827

Device

Generic name

Creatinine Reagent

Model number

R1/R2

Catalog number

1775677/1775766

Lot number

67848101/67846201

Patient

86 YR

Narrative

Description of Event or Problem

CANCER PATIENT WITH UNSPECIFIED "ILLNESS" WAS HOSPITALIZED BASED ON A CREATININE RESULT OF 13.8 MG/DL FROM THE SUSPECT DEVICE. THE FOLLOWING DAY, AN ALTERNATE METHOD (JAFFE REACTION) WAS USED TO ASSAY THE SAMPLE WITH A RESULT OF 2.0 MG/DL. THE TREATING PHYSICIAN BELIEVED THE 2.0 MG/DL VALUE BETTER FIT THE PATIENT'S CONDITION. THE PATIENT WAS TRANSFUSED WITH 2 UNITS OF BLOOD, BUT THE REPORTING TECHNICIAN DID NOT KNOW IF THIS WAS BEFORE OR AFTER THE CREATININE TEST.

Remedial action

  • Notification