COBAS 6000 C501MODULE

Description of Event or Problem

THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ION SELECTIVE ELECTRODE (ISE) SODIUM (NA), ISE POTASSIUM (K) AND ISE CHLORIDE (CL) ON ONE PATIENT SAMPLE. IT WAS DETERMINED THE ISE K RESULT WAS ERRONEOUS AND HAD BEEN REPORTED OUTSIDE OF THE LABORATORY. ALL RESULTS ARE IN MMOL/L. THE CUSTOMER HAD BEEN RECEIVING ISE INSTRUMENT ALARMS SINCE (B)(6) 2013. AFTER PERFORMING MULTIPLE TROUBLESHOOTING STEPS, THE CUSTOMER WAS ABLE TO ELIMINATE THE ISE INSTRUMENT ALARMS. AFTER ELIMINATING THE INSTRUMENT ALARM, THE CUSTOMER GOT A GOOD CALIBRATION AND GOOD QC AND RAN WITHOUT FURTHER INSTRUMENT ALARMS. IT WAS AFTER THIS THAT THE QUESTIONABLE RESULTS WERE GENERATED. THE SAMPLE IN QUESTION HAD AN INITIAL K RESULT OF 7.4, ACCOMPANIED BY A DATA FLAG. THERE WERE NO INSTRUMENT ALARMS AND THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501 ANALYZER AND GENERATED A REPEAT K RESULT OF 4.4. THE CUSTOMER DEEMED THE REPEAT RESULT TO BE THE CORRECT RESULT. THE INITIAL K RESULT WAS CORRECTED WITHIN A MINUTE OF THE ORIGINAL RESULT. THERE WAS NO ADVERSE EVENT. THE CUSTOMER INDICATED ABOUT 49 OTHER SAMPLES WERE RUN BEFORE THE SAMPLE IN QUESTION, WITH NO QUESTIONABLE RESULTS. THE LOT NUMBER AND EXPIRATION DATE FOR THE K ELECTRODE IN USE WAS ASKED FOR, BUT WAS NOT PROVIDED BY THE CUSTOMER. THE FIELD SERVICE REPRESENTATIVE FOUND THERE MAY HAVE BEEN SOME LEAKAGE IN THE ISE UNIT. HE CLEANED AND CHECKED THE ISE UNIT, SYRINGES AND DRAIN. HE PERFORMED DIAGNOSTICS AND PRECISION CHECKS.

Additional Manufacturer Narrative

THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. IT WAS NOTED THAT POSSIBLE ROOT CAUSES FOR THIS ISSUE COULD BE AIR IN THE SAMPLE CHANNEL, LEAKAGE CURRENT FROM THE WASTE AND AN OLD AND/OR EXPIRED REFERENCE ELECTRODE. THE TROUBLESHOOTING PERFORMED BY THE CUSTOMER, ALONG WITH THE SERVICE ACTIONS PERFORMED BY THE FIELD SERVICE REPRESENTATIVE (FSR) WERE VIEWED AS APPROPRIATE. THE CUSTOMER INDICATED THAT THEY HAVE NOT HAD ANY DISCREPANCIES OR ISSUES SINCE THE MODULE WAS SERVICED BY THE FSR.

Additional Manufacturer Narrative

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. RESULTS - DEVICE SUBASSEMBLY - ISE UNIT.