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
Manufacturer
Boehringer Mannheim Corp.Model number
R1/R2Catalog 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