Description of Event or Problem · 1
DURING A ROUTINE PRODUCT SURVEY, A PROGRAMMING ERROR WAS DISCOVERED WITH THE CREATININE LOT NUMBER F101 MEMO CHIP. AN INVESTIGATION INTO THE OCCURRENCE WAS LAUNCHED AND THE ERROR WAS VERIFIED ON (B)(4) 2011. IT WAS DETERMINED THAT THE "LOOK UP" TABLE PROGRAMMED IN THE MEMO CHIP CONTAINED A PROGRAMMING ERROR AT THE CONCENTRATION VALUE LABELED AS "1000", WHICH CORRESPONDS TO A CONCENTRATION OF 10 MG/DL. THE "1000" VALUE COLUMN WAS MISTAKENLY LABELED AS "100" WHICH WOULD RESULT IN THE MEMO CHIP INTERPRETING A CREATININE CONCENTRATION GREATER THAN 9 MG/DL AS A NUMBER BETWEEN OF 1 MG/DL AND 9 MG/DL. WITH FURTHER EVALUATION USING FRESH BLOOD AND STATIC TILE TESTING, ERRATIC RESULTS WERE OBTAINED FOR VALUES GREATER THAN 9 MG/DL BUT WERE ACCURATE FOR ALL VALUES LESS THAN 9 MG/DL. THE LOT HAD ONLY BEEN RELEASED TO CUSTOMERS IN THE PREVIOUS 3 WEEKS AND NO COMPLAINTS HAD BEEN LOGGED AGAINST THE LOT. THUS WE CALCULATED THE INCIDENCE OF AN ERROR OCCURRING TO BE VERY LOW DUE TO LIMITED DISTRIBUTION AND A SHORT TIME OF FIELD EXPOSURE AS WELL AS AN INFREQUENT LIKELIHOOD OF A PT HAVING THIS HIGH OF A VALUE. THUS THIS IS A LOW RISK. HOWEVER, IF AN ERRATIC/ERRONEOUS RESULT WAS TO OCCUR WITH A PT WHOM HAD A HIGH CREATININE LEVEL, THERE EXISTS A POTENTIAL RISK TO HEALTH. WE HAVE THUS UNDERTAKEN A FIELD CORRECTION FOR THIS LOT WHICH HAS ONLY BEEN DISTRIBUTED TO A VERY LIMITED NUMBER OF CUSTOMERS THROUGH ONE DEALER IN THE USA. MATERIAL WAS ALSO SENT TO A DISTRIBUTOR IN (B)(4) BUT NOT DISTRIBUTED TO ANY CUSTOMERS.