ROCHE 9180 ELECTROLYTE ANALYZER

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM RESULTS FROM THE ELECTROLYTE ANALYZER W/O STARTERKIT 9180. THE INITIAL RESULTS FOR THE SAMPLE WERE "BELOW 110 MMOL/L". AFTER CALIBRATION, THE REPEAT RESULT WAS 136 MMOL/L.

Additional Manufacturer Narrative

THE ELECTRODE LOT NUMBER AND EXP WERE NOT PROVIDED.

Additional Manufacturer Narrative

THE ELECTRODE LOT NUMBER WAS 31244547. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE QC RESULTS WERE WITHIN THE SPECIFIED RANGES. DUE TO THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THE EVENT WAS CONSISTENT WITH ISSUES WITH THE INTERPLAY BETWEEN SPECIFIC CORE COMPONENTS WITHIN THE SYSTEM (REFERENCE ELECTRODE, NA ELECTRODE, SNAPPAK), ALONG WITH POTENTIAL DEFICIENCIES IN THE MAIN INSTRUMENT'S OPERATION

Additional Manufacturer Narrative

THE ROOT CAUSE OF THE ISSUE WAS RELATED TO A REFERENCE ELECTRODE MANUFACTURED BY DIAMOND DIAGNOSTICS (DD REF ELECTRODE) USED WITH THE 9180 ELECTROLYTE ANALYZER. THE REFERENCE ELECTRODE USED (DD REF ELECTRODE) IS COVERED BY A ROCHE INITIATED RECALL. CUSTOMERS USING THE DD REF ELECTRODE WERE INSTRUCTED TO IMMEDIATELY STOP USING SODIUM (NA) RESULTS FROM THEIR 9180 ANALYZER. THE AFFECTED REFERENCE ELECTRODE WAS NOT DISTRIBUTED IN THE UNITED STATES. CUSTOMERS IN THE UNITED STATES USE ROCHE REFERENCE ELECTRODE AND REFERENCE ELECTRODE HOUSING. NO FURTHER ACTION IS NEEDED FOR CUSTOMERS IN THE UNITED STATES.