COBAS 6000 C501 MODULE
Received Feb 3, 2010 · Event occurred Jan 11, 2010
Report 1823260-2010-00748 · MDR key 1593245
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05036453001
Lot number
NA
Product problems
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
USER REPORTED OUT AN ERRONEOUS ALT RESULT OF 536 U/L FOR ONE PATIENT SAMPLE. SAMPLE TYPE IS PLASMA. ERRONEOUS RESULT WAS GENERATED FROM A SAMPLE ALIQUOTTED BY AN MPA SYSTEM. ON (B) (6) 2010, THE PHYSICIAN QUESTIONED THE RESULT AND REQUESTED THE PATIENT BE REDRAWN. THE REDRAWN SAMPLE GAVE 14 U/L. ON (B) (6) 2010 THE ORIGINAL PRIMARY SAMPLE TUBE WAS REPEATED ON ANOTHER C501 ANALYZER SERIAL NUMBER 75202 AT THE SITE GIVING 14 U/L. PHYSICIAN DID NOT ACT ON THE ERRONEOUS ALT RESULT REPORTED. PATIENT WAS NOT ADVERSELY AFFECTED. ALT REAGENT LOT NUMBER, 61893401 THE FIELD SERVICE REPRESENTATIVE FOUND THE SAMPLE PROBE WAS MISADJUSTED. HE ADJUSTED THE SAMPLE PROBE. TO VERIFY ANALYZER PERFORMANCE A PRECISION STUDY WAS RUN WITH NO ISSUES.