ISE 9180

Additional Manufacturer Narrative

INFORMATION WAS PROVIDED THAT THE SODIUM RESULT FROM THE ROCHE ANALYZER WAS "130 MMOL" AND THE RESULT FROM ANOTHER LABORATORY WAS "138 MMOL". THE SODIUM ELECTRODE LOT NUMBER WAS 21562347. RESULT PRINTOUTS COULD NOT BE PROVIDED NOR THE NA ELECTRODE THAT WAS USED IN THE ALLEGED MEASUREMENTS. NO FURTHER INFORMATION OR DATA WAS AVAILABLE FOR THIS COMPLAINT. TRENDING ON THE LOT NUMBER OF THE NA ELECTRODE SHOWED NO OTHER COMPLAINTS. THE CERTIFICATE OF ANALYSIS OF THIS ELECTRODE BATCH SHOWED NO INDICATION FOR THE COMPLAINED ISSUE. BASED ON THE INFORMATION PROVIDED, NO ISSUE COULD BE FOUND WITH THE ANALYZER. THE CUSTOMER WAS USING BIORAD QC MATERIAL WHICH IS NOT APPROVED FOR USE ON THIS ANALYZER. PRODUCT LABELING STATES THAT THE USE OF CONSUMABLES THAT WERE NOT PRODUCED BY ROCHE, INCLUDING BUT NOT LIMITED TO ELECTRODES, CALIBRATION AND CLEANING SOLUTIONS, QC-MATERIAL, AND RELATED ACCESSORIES MAY RESULT IN MALFUNCTION OF THE ANALYZER AND MAY LEAD TO INCORRECT PATIENT RESULTS.

Additional Manufacturer Narrative

(B)(4). THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER RECEIVED QUESTIONABLE ISE INDIRECT NA, K, CI FOR GEN.2 SODIUM RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES. SPECIFIC DATA WAS REQUESTED BUT WAS NOT PROVIDED. INFORMATION CONCERNING IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED, BUT IT WAS UNKNOWN. THERE WAS NO ADVERSE EVENT. THE ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT WERE NOT PROVIDED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS PROVIDED THAT THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE ELECTRODE WAS CLEANED AND QC WAS PERFORMED WHICH WAS IN RANGE.