THE CUSTOMER REPORTED THAT THEY HAVE BEEN HAVING PROBLEMS WITH LACTATE ON THE COBAS B221 ANALYZER. THE CUSTOMER HAS FOUND A DIFFERENCE IN LACTATE RESULTS WHEN COMPARING RESULTS FROM THIS COBAS B221 ANALYZER TO ANOTHER ONE IN THE LABORATORY. THEY HAVE FOUND THAT THERE IS A DIFFERENCE OF 0.5 MMOL/L ON THE LOW SIDE OF THE LACTATE MEASURING RANGE. THEIR CONTROL RECOVERY HAS ALSO SHOWN A NEGATIVE BIAS ON RECENT OCCASIONS. THE CUSTOMER ALSO STATED THAT THERE WERE OCCASIONS WHERE THEY HAVE HAD RESULTS BELOW THE MEASURING RANGE AND WHEN REPEATED ON THE COBAS B 221 ANALYZER IN THE LABORATORY, THEY GET AN ACTUAL VALUE SUCH AS 0.5 MMOL/L. THE ISSUE WAS INITIALLY THOUGHT TO BE DUE TO FLUIDICS. AN ENGINEER HAS PERFORMED ALL REQUIRED MAINTENANCE, BUT IT HAS NOT RESOLVED THE ISSUE. THE CUSTOMER ONLY PROVIDED EXAMPLES OF RESULTS FROM A TOTAL OF THREE PATIENTS. OF THESE THREE PATIENTS, ONE HAD ERRONEOUS RESULTS. THE PATIENT WAS INITIALLY TESTED 3 TIMES, GIVING VALUES OF 0.4 MMOL/L, 0.5 MMOL/L, AND 0.7 MMOL/L. WHEN TESTED ON THE LABORATORY ANALYZER, THE RESULT WAS 0.9 MMOL/L. IT IS UNKNOWN IF THESE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY OR USED FOR DIAGNOSTIC PURPOSES. IT IS UNKNOWN IF ANY PATIENTS WERE ADVERSELY AFFECTED. THIS INFORMATION WAS REQUESTED BUT NOT PROVIDED. NO ADVERSE EVENTS WERE ALLEGED. THE LACTATE CARTRIDGE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.
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Patient 1
THIS EVENT OCCURRED IN (B)(6).
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Patient 1
THE DATE OF THE EVENT HAS BEEN CONFIRMED TO BE (B)(6) 2014. INITIAL REPORTER NAME AND COUNTRY HAS BEEN UPDATED. INITIAL REPORTER OCCUPATION HAS BEEN UPDATED. IT WAS CONFIRMED THAT NO PATIENTS WERE ADVERSELY AFFECTED DUE TO THE EVENT. THE REPEAT RESULT OF 0.9 MMOL/L FROM THE LABORATORY INSTRUMENT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS GENERATED FROM THE SAME SAMPLE AS THE INITIAL RESULTS. THE PATIENTS WERE ALL ADULTS. THIS EVENT OCCURRED IN (B)(6).
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Patient 1
A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. THE CALIBRATION SIGNALS FOR LACTATE SHOW NORMAL BEHAVIOR AND DO NOT HINT TOWARDS A SENSOR OR SYSTEM PROBLEM. AN ANALYSIS OF THE SYSTEM DATABASE DID NOT REVEAL ANY INDICATIONS THAT THE REPORTED RESULTS COULD BE CAUSED BY A MALFUNCTION OF THE SYSTEM. IT WAS NOTED THAT THE MSS SENSOR WHICH WAS ON BOARD AT THE TIME OF THE REPORTED MEASUREMENTS, WAS INSTALLED AT THE CUSTOMER SITE WITHOUT READING OF THE BAR CODE. THIS MEANS THAT THE SENSOR WAS NOT INSTALLED AS SPECIFIED AND ALL INFORMATION REGARDING THE LOT NUMBER AND EXPIRATION DATE WAS NOT RECOVERED IN THE SOFTWARE. AS A CONSEQUENCE, THE WETTING ROUTINE WOULD NOT HAVE BEEN STARTED AUTOMATICALLY BY THE SOFTWARE AND THE ON BOARD TIME OF THE SENSOR ALSO WOULD NOT HAVE BEEN COUNTED BY THE SOFTWARE.