COBAS 6000 C501 (UL) V

Additional Manufacturer Narrative

A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL DETAILS WERE REQUESTED BUT NOT PROVIDED.

Additional Manufacturer Narrative

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

Description of Event or Problem

THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) POTASSIUM AND SODIUM RESULTS FOR ONE PATIENT ON THEIR C501 ANALYZER. THE CUSTOMER PROVIDED DATA FOR ONE DISCREPANT POTASSIUM RESULT THAT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S SAMPLE WAS PROCESSED THROUGH THE CUSTOMER'S MODULAR PRE ANALYTICS DEVICE. THE PATIENT'S INITIAL POTASSIUM RESULT WAS 7.1 MMOL/L. THE CUSTOMER STATED SHE CALLED THE DOCTOR WITH THIS "CRITICAL" POTASSIUM RESULT. THE CUSTOMER REPEATED THE ENTIRE SAMPLE AND THE POTASSIUM RESULT WAS 3.8 MMOL/L. THE OTHER ASSAYS REPEATED WELL WITH THE INITIAL RESULTS WITH THE EXCEPTION OF THE INITIAL, QUESTIONABLE SODIUM RESULT, WHICH WAS NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE POTASSIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE AND COULD NOT DUPLICATE THE ISSUE. HE PERFORMED ISE CHECKS AND A PRECISION RUN. THE ISE CHECKS PERFORMED WITHOUT ANY ERRORS AND THE PRECISION RESULTS WERE WITHIN SPECIFICATION. THE INSTRUMENT WAS OPERATING WITHIN SPECIFICATION.