COBAS 6000 C501MODULE
Received Nov 15, 2010 · Event occurred Oct 21, 2010
Report 1823260-2010-06745 · MDR key 1899046
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04745914001
Lot number
NA
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE USER RECEIVED QUESTIONABLE RESULTS FOR ALANINE TRANSAMINASE (ALT) ON THE COBAS 6000 C501 (C3) MODULE. THE EVENT INVOLVED FIVE PATIENT SAMPLES. ONE PATIENT SAMPLE GAVE DISCREPANT RESULTS. THE PATIENT SAMPLE WAS REPEATED ON A DIFFERENT C501 MODULE (C2). THE INITIAL ALT RESULT WAS 5 U/L, THE REPEAT RESULT WAS 23 U/L. THE PATIENT WAS NOT AFFECTED AS THE INITIAL ALT RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE REAGENT LOT NUMBER FOR ALT WAS NOT PROVIDED.
Additional Manufacturer Narrative
SINCE THE CUSTOMER COULD NOT PROVIDE ANY PATIENT DATA FOR EVALUATION, A ROOT CAUSE COULD NOT BE IDENTIFIED.
Additional Manufacturer Narrative
THE EVENT OCCURRED IN (B)(6).