MalfunctionCGL
STATSENSOR CREATININE HOSPITAL METER
Received Jan 27, 2010 · Event occurred Jan 15, 2010
Report 1219029-2010-00001 · MDR key 1593542
Device
Generic name
Cgl - Electrode, Ion Based, Enzymatic Cr
Manufacturer
Nova BiomedicalModel number
44011 - METERCatalog number
43370 - TEST STRIP
Lot number
STRIP - 4909317249
Product problems
- Low Test Results
Patient
UNKNOWN
- No Information
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT A PT CREATININE RESULT FROM A STATSENSOR METER WAS 1.1 MG/DL VERSUS A RESULT OF 3.0 MG/DL FROM A BECKMAN DXC ANALYZER. SAMPLE TYPE PLASMA FROM A GREEN TOP TUBE. QUALITY CONTROL RUN BEFORE AND AFTER THE EVENT WERE ACCEPTABLE. NO MAINTENANCE WAS DONE TO DEVICE BEFORE OR AFTER THE EVENT. AFTER THE REPORTED EVENT COMPARISON TESTING WAS PERFORMED BETWEEN THE STATSENSOR METER AND THE BECKMAN DXC ANALYZER WITHOUT INCIDENT.