Description of Event or Problem · 1
A CYSTIC FIBROSIS SCREEN WAS ORDERED ON A BLOOD DRAW. THE PATIENT'S ORIGINAL CF TEST WAS RAN FIVE DAYS AFTER THE ORIGINAL BLOOD DRAW AND CAME UP WITH A S549R T>G (HET) MUTATION. QC PASSED AND THE LOT NUMBER OF CF CARD REAGENT USED WAS U24CF. THE SPECIMEN WAS RE-EXTRACTED AND REPEATED X2 SEVEN DAYS AFTER THE FIRST TEST WAS RUN AND, AGAIN, EACH CAME UP WITH A S549R T>G (HET) MUTATION. QC PASSED AND CF CARD REAGENT LOT NUMBER U24CF WAS USED. OUR MEDICAL DIRECTOR REVIEWED ALL RUN PAPERWORK (AS IS OUR POLICY) AND GAVE THE OK TO RESULT PATIENT AS HAVING THE S549R T>G MUTATION (HET), MEANING SHE WAS A CF CARRIER. THE RESULT WAS FINAL REPORTED APPROXIMATELY TWO WEEKS AFTER THE FIRST TEST WAS RUN. FOUR DAYS AFTER THE FINAL REPORT WAS MADE, THE MANUFACTURING COMPANY SUGGESTED THAT WE REPEAT THE PATIENT'S SPECIMEN AGAIN SINCE WE HAD BEEN HAVING OTHER NEAR-MISSES WITH THIS PARTICULAR MUTATION. OUR MEDICAL DIRECTOR CONTACTED THE PATIENT'S ORDERING PHYSICIAN ON THE SAME DAY THE MANUFACTURER SUGGESTED REPEATING THE TEST TO ALERT THE PHYSICIAN NOT DO ANY FURTHER WORKUP ON THIS PATIENT BECAUSE IT WOULD BE REPEATED. OUR MEDICAL DIRECTOR AGREED TO REPEAT SO WE RE-EXTRACTED IT AND REPEATED IT X2 IN-HOUSE AND SENT IT TO OUR REFERENCE LAB; REPORT WAS FINALIZED FIVE DAYS LATER. ALL OF THIS TESTING CAME OUT NEGATIVE. FOR THIS RUN, QC PASSED AND A DIFFERENT LOT NUMBER OF CF CARD REAGENT WAS USED (U24DG). OUR MEDICAL DIRECTOR WAS NOTIFIED OF THE REPEAT TESTING RESULTS FROM BOTH IN-HOUSE AND THE OUTSIDE LAB AND SHE NOTIFIED THE ORDERING PHYSICIAN THAT WE WOULD BE CHANGING THE RESULT TO "NEGATIVE" FOR THIS PATIENT. THE PATIENT'S RESULT WAS CHANGED. NO FURTHER WORKUP HAD BEEN DONE ON THE PATIENT SO THE PATIENT DID NOT SEEM TO BE HARMED.THE CF CARD LOT NUMBER U24CF, WHICH SEEMED TO BE WHAT WAS CAUSING THE PROBLEM, WAS PUT INTO USE AND WAS ACTIVE FOR APPROXIMATELY FOUR WEEKS. WE SENT THE REMAINING CARDS OF THIS LOT NUMBER BACK TO THE COMPANY AND DON'T HAVE ANY MORE IN-HOUSE.PLEASE NOTE: MOST OF THE PATIENTS WE TEST ARE PREGNANT/PLANNING TO GET PREGNANT AND ARE TESTING TO SEE IF THEY ARE CARRIERS OF A CF MUTATION (HETEROZYGOUS (HET) FOR ONE MUTATION). WE CAN ALSO TEST TO SEE IF A PATIENT HAS CF (HOMOZYGOUS MUTANT (MUT) FOR ONE MUTATION OR HETEROZYGOUS FOR TWO DIFFERENT MUTATIONS).WE EXTRACT DNA FOR EACH PATIENT WE GET IN FOR TESTING AND THEN WE BATCH SAMPLES AND RUN THEM TWICE A WEEK. IF A SAMPLE COMES UP WITH A MUTATION (EITHER HET OR MUT), WE RE-EXTRACT AND RE-RUN THE SAMPLE X2 (FOR A TOTAL OF 3 RESULTS, EACH A NEW DNA EXTRACTION).THERE WERE 8 OTHER PATIENTS WHERE THIS EXTRACT WAS USED, HOWEVER THERE WAS NO HARM AND THE EVENT DID NOT REACH THE PATIENTS, THEY WERE CAUGHT BEFOREHAND.======================MANUFACTURER RESPONSE FOR CYSTIC FIBROSIS CARD REAGENT, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================THE MANUFACTURER SUGGESTED THAT WE REPEAT THE TEST.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CYSTIC FIBROSIS SCREEN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?YES.THIS PROBLEM INVOLVED: THE REAGENT.IS THIS A RECURRING PROBLEM WITH THIS ASSAY, TEST KIT OR INSTRUMENT?YES.WHICH OF THE FOLLOWING PROBLEMS DID YOU OBSERVE:OTHER.IF YOU ANSWERED OTHER TO THE QUESTION ABOVE, PLEASE PROVIDE ADDITIONAL COMMENTS:PLEASE SEE NARRATIVE ON PREVIOUS PT UNDER EVENT.PLEASE DESCRIBE ANY FOLLOW UP ACTIONS:REPEATED ASSAY, RESULTS OK, REPORTED OUT.REPLACED REAGENTS.MANUFACTURER NOTIFIED.DISCONTINUED ALL USE OF PRODUCT.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?YES.THIS PROBLEM INVOLVED: THE REAGENT.IS THIS A RECURRING PROBLEM WITH THIS ASSAY, TEST KIT OR INSTRUMENT?YES.WHICH OF THE FOLLOWING PROBLEMS DID YOU OBSERVE:OTHER.IF YOU ANSWERED OTHER TO THE QUESTION ABOVE, PLEASE PROVIDE ADDITIONAL COMMENTS:PLEASE SEE NARRATIVE ON PREVIOUS PT UNDER EVENT.PLEASE DESCRIBE ANY FOLLOW UP ACTIONS:REPEATED ASSAY, RESULTS OK, REPORTED OUT.REPLACED REAGENTS.MANUFACTURER NOTIFIED.DISCONTINUED ALL USE OF PRODUCT.DEVICE #3IS THIS A LABORATORY DEVICE OR LABORATORY TEST?YES.THIS PROBLEM INVOLVED:THE REAGENTIS THIS A RECURRING PROBLEM WITH THIS ASSAY, TEST KIT OR INSTRUMENT?YES.WHICH OF THE FOLLOWING PROBLEMS DID YOU OBSERVE:OTHER.IF YOU ANSWERED OTHER TO THE QUESTION ABOVE, PLEASE PROVIDE ADDITIONAL COMMENTS:PLEASE SEE NARRATIVE ON PREVIOUS PT UNDER EVENT.PLEASE DESCRIBE ANY FOLLOW UP ACTIONS:REPEATED ASSAY, RESULTS OK, REPORTED OUT.REPLACED REAGENTS.MANUFACTURER NOTIFIED.DISCONTINUED ALL USE OF PRODUCT.DEVICE #4IS THIS A LABORATORY DEVICE OR LABORATORY TEST?YES.THIS PROBLEM INVOLVED: THE REAGENT.IS THIS A RECURRING PROBLEM WITH THIS ASSAY, TEST KIT OR INSTRUMENT?YES.WHICH OF THE FOLLOWING PROBLEMS DID YOU OBSERVE:OTHER.IF YOU ANSWERED OTHER TO THE QUESTION ABOVE, PLEASE PROVIDE ADDITIONAL COMMENTS:PLEASE SEE NARRATIVE ON PREVIOUS PT UNDER EVENT.PLEASE DESCRIBE ANY FOLLOW UP ACTIONS:REPEATED ASSAY, RESULTS OK, REPORTED OUT.REPLACED REAGENTS.MANUFACTURER NOTIFIED.DISCONTINUED ALL USE OF PRODUCT.DEVICE #5IS THIS A LABORATORY DEVICE OR LABORATORY TEST?YES.THIS PROBLEM INVOLVED: THE REAGENT.IS THIS A RECURRING PROBLEM WITH THIS ASSAY, TEST KIT OR INSTRUMENT?YES.WHICH OF THE FOLLOWING PROBLEMS DID YOU OBSERVE:OTHER.IF YOU ANSWERED OTHER TO THE QUESTION ABOVE, PLEASE PROVIDE ADDITIONAL COMMENTS:PLEASE SEE NARRATIVE ON PREVIOUS PT UNDER EVENT.PLEASE DESCRIBE ANY FOLLOW UP ACTIONS:REPEATED ASSAY, RESULTS OK, REPORTED OUT.REPLACED REAGENTS.MANUFACTURER NOTIFIED.DISCONTINUED ALL USE OF PRODUCT.DEVICE #6IS THIS A LABORATORY DEVICE OR LABORATORY TEST?YES.THIS PROBLEM INVOLVED: THE REAGENT.IS THIS A RECURRING PROBLEM WITH THIS ASSAY, TEST KIT OR INSTRUMENT?YES.WHICH OF THE FOLLOWING PROBLEMS DID YOU OBSERVE:OTHER.IF YOU ANSWERED OTHER TO THE QUESTION ABOVE, PLEASE PROVIDE ADDITIONAL COMMENTS:PLEASE SEE NARRATIVE.