Description of Event or Problem · 0
PRODUCT NAME: DI-60 UDI: (B)(4). SERIAL NUMBER: (B)(6). DATE OF MANUFACTURE: 2019-04 ACCESSORIES: N/A SW VER. NO.: CDMS 7.0.3 BUILD 18 REFERENCES: CUSTOMER COMPLAINT REPORT: (B)(4). COMPLAINT INVESTIGATION: (B)(4). VIGILANCE REPORTS: (B)(4). SUMMARY DESCRIPTION OF THE PROBLEM ON MARCH 18TH, 2024, CELLAVISION AB RECEIVED AN E-MAIL FROM SYSMEX AMERICA INC. (SAI) REPORTING A COMPLAINT ABOUT A CELLAVISION AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER (DI-60). THE COMPLAINT ALLEGES THAT AN INCORRECT RESULT HAD BEEN REPORTED RESULTING IN A BONE MARROW ASPIRATION FOR ONE PATIENT. THE INCIDENT WAS TO BE REPORTED BY SAI AS AN ADVERSE EVENT. FURTHER INVESTIGATION OF THE COMPLAINT FOUND THE FOLLOWING: DATE OF EVENT(S): · PATIENT A: SEPTEMBER 10, 2023 · PATIENT B: FEBRUARY 3, 2024 PATIENT A: AGE: 71 SEX: FEMALE SAMPLE ID: (B)(6) AUER ROD MISCLASSIFICATION BY OPERATOR LIKELY LED TO ADDITIONAL BONE MARROW ASPIRATION TESTING. SUBSEQUENT TESTING FOUND "NEGATIVE WITH NO SIGNS OF LEUKEMIA." PATHOLOGIST REVIEW CONFIRMED NO AUER RODS PRESENT IN THE ORIGINAL SLIDE. PATIENT B: AGE: 26 SEX: FEMALE SAMPLE ID: (B)(6) AUER ROD MISCLASSIFICATION BY OPERATOR LIKELY LED TO REFERRAL TO ONCOLOGIST, ADDITIONAL CBC/DIFF TESTING, AND "LEUKEMIA BLOOD" TESTING. SUBSEQUENT TESTING FOUND NO AUER RODS AND WAS "NEGATIVE FOR LEUKEMIA." DI-60 IMAGES AND ORIGINAL SLIDE UNAVAILABLE FOR FURTHER REVIEW DUE TO DELETION CYCLES. OUTCOME NO AUER RODS OR SIGNS OF LEUKEMIA WERE FOUND IN ADDITIONAL TESTING FOR EITHER PATIENT. THE PATIENT RECEIVING BONE MARROW ASPIRATION SUFFERED NO SERIOUS CONSEQUENCES. ROOT CAUSE OUR INVESTIGATION INTO THE REPORTED MISCLASSIFICATION OF LARGE THROMBOCYTES AS AUER RODS BY THE DI-60 ANALYZER INVOLVED A REVIEW OF RAW DATA AND ADDITIONAL IN-HOUSE TESTING. THIS EVALUATION CONFIRMED THAT THE ANALYZER FUNCTIONED AS INTENDED ACCORDING TO ITS SPECIFICATIONS. THE DI-60 ANALYZER IS DESIGNED TO AID IN BLOOD CELL CLASSIFICATION, BUT THE FINAL DETERMINATION RELIES ON A SKILLED OPERATOR'S REVIEW AND VERIFICATION OF THE SUGGESTED PRE-CLASSIFICATION. THE CELLAVISION DM CONFIGURATION ALLOWS AN ADMINISTRATOR TO ADD USER-DEFINED CELL CLASSES. THE USER CAN RECLASSIFY CELLS TO THESE CELL CLASSES AND REPORT THEM TO LIS. HOWEVER, NO PRE-CLASSIFICATION BY THE SYSTEM IS EVER MADE TO THESE CELL CLASSES. IN THIS SPECIFIC INSTANCE, THE USER HAD ADDED THE TWO USER-DEFINED CELL CLASSES "AUER RODS" AND "LARGE THROMBOCYTES". THE OPERATOR THEN MISTAKENLY RECLASSIFIED LARGE THROMBOCYTES AS AUER RODS. THIS CONCLUSION IS SUPPORTED BY THE CUSTOMER REPORT STATING THAT SAI HAD FOLLOWED UP WITH THE CUSTOMER ON MARCH 15TH, 2024. THE CUSTOMER CONFIRMED THAT THIS WAS OPERATOR ERROR, LIKELY OCCURRING BECAUSE AUER RODS AND LARGE PLATELETS ARE NEXT TO EACH OTHER ON THE RECLASSIFICATION DROPDOWN. TO ADDRESS THIS POTENTIAL USER ERROR, WE HAVE PERFORMED THE FOLLOWING ACTIONS: ACTION 1: THE CELLAVISION DM SOFTWARE INCORPORATES SEVERAL PRE-EXISTING RISK MITIGATION STRATEGIES THAT ALREADY ADDRESS THE THE RISK OF MISCLASSIFICATION DUE TO THE CLOSE PROXIMITY OF DIFFERENT CELL CLASSES IN THE RECLASSIFICATION DROPDOWN MENU. THESE MEASURES INCLUDE: HIGHLIGHTING THE SELECTED CELL CLASS: THE CELL CLASS THAT THE CELLS ARE DROPPED INTO IS HIGHLIGHTED TO INCREASE USER AWARENESS AND REDUCE THE LIKELIHOOD OF ACCIDENTAL MISCLASSIFICATION. MARKING RECLASSIFIED CELLS: CELLS THAT ARE MANUALLY RECLASSIFIED BY THE OPERATOR WILL BE MARKED WITH A SPECIAL INDICATOR. THIS WILL HELP USERS TO EASILY IDENTIFY CELLS THAT HAVE BEEN MOVED FROM THEIR ORIGINAL PRE-CLASSIFICATION, PROVIDING AN ADDITIONAL OPPORTUNITY FOR VERIFICATION. ADDITIONALLY, THE WORKFLOW IN THE CELLAVISION DM SOFTWARE ALSO INCLUDES A MANDATORY REVIEW OF SLIDE RESULTS BEFORE THE RESULT CAN BE REPORTED. THESE EXISTING MITIGATION STRATEGIES, COUPLED WITH THE FACT THAT WE HAVE NOT ENCOUNTERED SIMILAR MISCLASSIFICATION REPORTS PREVIOUSLY WITHIN OUR COMPLAINT HISTORY LEADS US TO BELIEVE THAT THEY ARE EFFECTIVE IN REDUCING THE RISK OF MISCLASSIFICATION ERRORS. HOWEVER, WE WILL CONTINUE TO MONITOR THE SITUATION AND TAKE FURTHER STEPS AS NEEDED. ACTION 2: WE CONDUCTED AN INVESTIGATION TO RULE OUT THE POSSIBILITY OF A SOFTWARE BUG THAT COULD HAVE CAUSED THE MISCLASSIFICATION OF LARGE THROMBOCYTES AS AUER RODS. TEST PROCEDURE: · FIVE USER-DEFINED NWBC CLASSES WERE CREATED IN THE DM CONFIGURATION TOOL, INCLUDING "AUER RODS" AND "LARGE THROMBOCYTES." · CELLS WERE CLASSIFIED AS "LARGE THROMBOCYTES" USING THE DROP-DOWN LIST IN THE WBC GALLERY. · THE RESULTS WERE VERIFIED, AND THE CELLS WERE CONFIRMED TO BE CORRECTLY CLASSIFIED AS "LARGE THROMBOCYTES." TEST CONCLUSION: THE TEST RESULTS CONFIRMED THAT THE SOFTWARE FUNCTIONS AS INTENDED AND DOES NOT EXHIBIT ANY BUGS THAT COULD HAVE CAUSED THE REPORTED MISCLASSIFICATION. THE ISSUE IS THEREFORE ATTRIBUTED TO USER ERROR DURING THE CELL CLASSIFICATION PROCESS. RISK EVALUATION SEE CI124-001 APPENDIX A - HHE CONCLUSION THE INVESTIGATION CONCLUDED THAT THE CELLAVISION DI-60 DEVICE PERFORMED AS INTENDED. NO REMEDIAL/CORRECTIVE/PREVENTIVE/FIELD SAFETY CORRECTIVE ACTIONS TAKEN BY CELLAVISION. CELLAVISION WILL SUBMIT A MEDICAL DEVICE REPORT (MDR) TO THE FDA REGARDING THIS REPORTED ADVERSE EVENT.