COBAS 6000 C501 MODULE
Received Jan 25, 2011 · Event occurred Jan 10, 2011
Report 1823260-2011-00378 · MDR key 1970174
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05036453001
Lot number
NA
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER HAS RECEIVED INSTRUMENT ERRORS AND QUESTIONABLE ALKALINE PHOSPHATASE GEN.2 (ALP2) RESULTS SINCE (B)(6) 2010. SHE PROVIDED ALP2 RESULTS FOR TEN PATIENT SAMPLES, ONE SAMPLE HAD DISCREPANT RESULTS. THE ORIGINAL RESULT WAS 11 U/L. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501 (SERIAL NUMBER (B)(4)) AND RECOVERED 124 U/L. THE ORIGINAL RESULT WAS REPORTED OUTSIDE THE LABORATORY AND A CORRECTED REPORT WAS SENT OUT THE SAME DAY. NO PATIENTS WERE ADVERSELY AFFECTED BY THE EVENT. THE ALP2 REAGENT LOT NUMBER WAS 63013201. THE FIELD SERVICE REPRESENTATIVE CONTACTED THE CUSTOMER. THE CUSTOMER PERFORMED MAINTENANCE WHICH RESOLVED THE ISSUE.