COBAS 6000 C501MODULE

Description of Event or Problem

THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ION SELECTIVE ELECTRODE (ISE) SODIUM (NA) ON ONE PATIENT SAMPLE. ALL RESULTS ARE IN MMOL/L. THE CUSTOMER NOTICED THAT THE ISE DILUENT BOTTLE DID NOT SWITCH OVER WHEN IT WAS EMPTY, AND AN ERRONEOUS RESULT WAS GENERATED. THE CUSTOMER ALSO NOTICED AT THE SAME TIME THAT THE SOFTWARE INDICATED THERE WERE 150 TESTS REMAINING IN THE ISE REFERENCE ELECTROLYTE (KCL) WHEN THE BOTTLE WAS ALMOST EMPTY. THE CUSTOMER REPLACED THE DILUENT AND KCL AND PRIMED AND IT WAS BACK TO NORMAL. THE ORIGINAL NA RESULT WAS 154, WHICH WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501 MODULE AND GENERATED A REPEAT RESULT OF 136. THE CUSTOMER DEEMED THE REPEAT RESULT TO BE THE CORRECT RESULT. THERE WAS NO ADVERSE EVENT. THE LOT NUMBER OF THE NA ELECTRODE WAS NOT PROVIDED BY THE CUSTOMER. THE FIELD SERVICE REPRESENTATIVE FOUND THAT THE ISE PROBE LIQUID LEVEL DETECTION DID NOT PROPERLY DETECT THE LOW ISE REAGENT VOLUME STATUS. HE REPLACED THE ISE PROBE AND THE LIQUID LEVEL DETECTION PCB. HE RETAUGHT ISE PROBE COORDINATES. THE CUSTOMER CALIBRATED AS NEEDED. ALL CONTROLS WERE ACCEPTABLE TO THE CUSTOMER AND THE SYSTEM WAS PERFORMING TO SPECIFICATIONS.

Additional Manufacturer Narrative

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