SODIUM ELECTRODE

Additional Manufacturer Narrative

THE NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 4 PATIENT SAMPLES ON A 9180 ELECTROLYTE ANALYZER. THE CUSTOMER QUESTIONED THE INITIAL LOW RESULTS WHICH PROMPTED THEM TO REPEAT THE SAMPLES. FOR SAMPLE 1, THE INITIAL NA RESULT WAS 124. THE FIRST REPEAT RESULT WAS 137. THE SECOND REPEAT RESULT WAS 139. FOR SAMPLE 2, THE INITIAL NA RESULT WAS 131. THE FIRST REPEAT RESULT WAS 135. THE SECOND REPEAT RESULT WAS 153. FOR SAMPLE 3, THE INITIAL NA RESULT WAS 119. THE FIRST REPEAT RESULT WAS 138. THE SECOND REPEAT RESULT WAS 143. FOR SAMPLE 4, THE INITIAL NA RESULT WAS 135. THE FIRST REPEAT RESULT WAS 153. THE SECOND REPEAT RESULT WAS 153. THE UNITS OF MEASUREMENT WERE NOT PROVIDED.

Additional Manufacturer Narrative

QUALITY CONTROLS WERE LAST MEASURED 4 MONTHS PRIOR TO THE EVENT. PER PRODUCT LABELING: "QC MEASUREMENTS MUST BE PERFORMED IN THEIR ENTIRETY (I.E., ALL THREE QC LEVELS MUST BE MEASURED). OMITTING QC MEASUREMENTS OR IGNORING QC MEASUREMENT RESULTS MAY LEAD TO INCORRECT PATIENT MEASUREMENTS, WHICH MAY RESULT IN INCORRECT CLINICAL DECISIONS, POSSIBLY ENDANGERING THE PATIENT'S HEALTH." PRODUCT LABELING ALSO STATES: "IN ORDER TO ENSURE THE QUALITY OF THE MEASUREMENT RESULTS, COMPLETE A QUALITY CONTROL TEST ON THREE LEVELS (1=LOW, 2=NORMAL, 3=HIGH) AFTER EACH ELECTRODE EXCHANGE, AFTER EACH REPLACEMENT OF THE SNAPPAK, AFTER STARTUP OF THE INSTRUMENT AS WELL AS AFTER MONTHLY, SEMI ANNUAL AND ANNUAL MAINTENANCE STEPS. ADDITIONALLY, AT LEAST ONCE DAILY ONE QC MEASUREMENT HAS TO BE PERFORMED IN ALTERNATING LEVELS (1=LOW, 2=NORMAL, 3=HIGH) (E.G., DAY 1 - LEVEL 1, DAY 2 - LEVEL 2, DAY 3 - LEVEL 3, DAY 4 - LEVEL 1, ETC.). WHEN REQUIRED BY LOCAL REGULATIONS, QC MEASUREMENTS MUST BE PERFORMED MORE OFTEN." ELECTRODES WERE PROVIDED FOR INVESTIGATION AND THE ELECTRODES WERE EXPIRED. THE EXPIRED ELECTRODES ARE THE ROOT CAUSE FOR THE ISSUE. MEDWATCH FIELDS D1, D2, D4, G1, AND G4 HAVE BEEN UPDATED.

Additional Manufacturer Narrative

G1 CONTACT OFFICE-MANUFACTURING SITE WAS UPDATED.