AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60

Additional Manufacturer Narrative

THE ISSUE HAS BEEN INVESTIGATED AND DETERMINED TO OCCUR ONLY UNDER VERY SPECIFIC CONDITIONS. THE MALFUNCTION IS ASSOCIATED WITH IME (INPUT METHOD EDITORS) FOR SIMPLIFIED CHINESE USED IN SPECIFIC VERSIONS OF WINDOWS 10 (SUCH AS, VERSIONS 1903, 2004, 21H2, 22H2). IMES ARE USED TO ENABLE INPUT OF COMPLEX CHARACTERS AND MAY AFFECT HOW NUMERIC VALUES ARE PROCESSED BY THE SOFTWARE. THE PROBLEM ONLY EXISTS ON SOME WINDOWS 10 VERSIONS AND NOT ON WINDOWS 11 AND ONLY OCCURS WITH SIMPLIFIED CHINESE WINDOWS LANGUAGE. THE ISSUE IS THEREFORE LIMITED TO SPECIFIC COMBINATIONS OF OPERATING SYSTEM VERSION, IME BEHAVIOUR, AND LANGUAGE SETTINGS IN CONJUNCTION WITH CELLAVISION® DM SOFTWARE VERSION 7.2.0.7. A NEW SOFTWARE VERSION IS UNDER DEVELOPMENT WHICH WILL CORRECT THE IDENTIFIED ISSUE. THE CORRECTED SOFTWARE VERSION WILL BE MADE AVAILABLE TO ALL USERS, BUT WILL ONLY BE INSTALLED THROUG A RECALL IN MARKETS WHERE SIMPLIFIED CHINESE IS COMMONLY USED AND THE AFFECTED SOFTWARE VERSION HAS BEEN INTRODUCED ON THE MARKET. FOR THE US MARKET NO SYSTEMS HAVE RECIEVED THIS AFFECTED SOFTWARE VERSION, AND NO SYSTEMS WILL BE PUT ON THE MARKET OR RECIEVE THE AFFECTED SOFTWARE IN THE FUTURE. WITHIN THE US, SIMPLIFIED CHINESE IS NOT COMMONLY USED AS INPUT LANGUAGE IN PROFESSIONAL LABORATORY OR CLINICAL SETTINGS. THE PROBABILITY OF OCCURRENCE FOR THE ASSOCIATED HAZARD WITHIN THE US IS ASSESSED AS REMOTE OR NEGLIGIBLE. ALTHOUGH IF THE ISSUE WERE TO OCCUR, IT COULD POTENTIALLY AFFECT NUMERIC INPUT UNDER THE DESCRIBED CIRCUMSTANCES. HOWEVER, EXISTING LABORATORY PROCEDURES AND CLINICAL DIAGNOSTIC PROCEDURES FURTHER REDUCE THE LIKELIHOOD OF ANY IMPACT ON PATIENT RESULTS. NO INCIDENTS ASSOCIATED WITH THIS ISSUE HAVE BEEN REPORTED, THE ISSUE WAS DISCOVERED DURING NON-CLINICAL USE AS PART OF TRAINING WITHIN A LABORATORY IN CHINA. BASED ON THE SPECIFIC CONDITIONS REQUIRED FOR THE MALFUNCTION TO OCCUR, ALONG WITH THAT NO SYSTEMS ON THE MARKET IN THE US HAVE RECIEVED THE AFFECTED SOFTWARE, THE RISK IS ASSESSED AS NIGLIGIBLE. THEREFORE, A FIELD CORRECTION IS NOT CONSIDERED NECESSARY.

Description of Event or Problem

A SOFTWARE DEFECT HAS BEEN IDENTIFIED IN CELLAVISION® DM SOFTWARE VERSION 7.2.0.7 WHEN USED ON CERTAIN WINDOWS 10 SYSTEMS WITH SIMPLIFIED CHINESE AS THE WINDOWS LANGUAGE DURING SMEAR REVIEW IN THE REVIEW SOFTWARE. THE DEFECT AFFECTS THE INTERPRETATION OF MANUALLY ENTERED PLATELET (PLT) COUNTS FOR THE METHOD "COUNT PLTS PER GRID SQUARE". THE SOFTWARE MAY INCORRECTLY PROCESS NUMERICAL INPUTS DUE TO INPUT METHOD EDITOR (IME) BEHAVIOUR, SPECIFICALLY, THE LAST DIGIT IN MULTI-DIGIT VALUES CAN BE INCORRECTLY ELIMINATED IN THE CALCULATION OF PLATELETS PER HIGH-POWER FIELD (PLT/HPF). THE ISSUE CAN CAUSE INCORRECT INTERPRETATION OF INPUT VALUES FOR MANUAL PLT (PLATELET) COUNTS LEADING TO ERRONEOUSLY LOW PLT ESTIMATIONS. ERRONEOUS PLT RESULTS PROVIDE INCORRECT INPUT FOR DIAGNOSTIC DECISIONS, ALTHOUGH THEY ARE SELDOM THE ONLY INPUT IN CLINICAL DECISIONS. NEVERTHELESS, THERE REMAINS A RISK OF HARM IF THE MALFUNCTION WERE TO OCCUR, SUCH AS DELAYED OR INCORRECT DIAGNOSIS, UNNECESSARY OR INAPPROPRIATE TREATMENT OR DELAY IN APPROPRIATE TREATMENT. NO INCIDENTS OR ADVERSE EVENTS ASSOCIATED WITH THIS ISSUE HAVE BEEN REPORTED. THE ISSUE WAS DISCOVERED DURING NON-CLINICAL USE AS PART OF TRAINING WITHIN A LABORATORY IN CHINA. THE AFFECTED SOFTWARE VERSION, CDMS 7.2.0.7, HAD BEEN AVAILABLE FOR DOWNLOAD SINCE MARCH 2026. INSTALLATION OF THE SOFTWARE FOR SYSTEMS IN THE FIELD REQUIRED SUPPORT FROM SERVICE PERSONNEL. THE SW VERSION HAS NOT BEEN INTRODUCED IN PRODUCTION YET AND THUS NO NEW SYSTEMS HAVE BEEN RELEASED WITH THIS SOFTWARE VERSION. THE ISSUE IS LIMITED TO SPECIFIC COMBINATIONS OF OPERATING SYSTEM VERSION, IME BEHAVIOUR, AND USE OF SIMPLIFIED CHINESE WINDOWS LANGUAGE IN CONJUNCTION WITH CELLAVISION® DM SOFTWARE VERSION 7.2.0.7. IN COUNTRIES WHERE KNOWLEDGE OF SIMPLIFIED CHINESE, SUCH AS THE US, IS LIMITED TO A VERY SMALL PROPORTION OF THE POPULATION, ITS USE IN PROFESSIONAL LABORATORY OR CLINICAL CONTEXTS IS HIGHLY UNLIKELY. THE PROBABILITY OF THE ASSOCIATED HAZARD WITHIN THESE MARKETS IS ASSESSED AS REMOTE OR NEGLIGIBLE. ALTHOUGH THE ISSUE COULD POTENTIALLY AFFECT NUMERIC INPUT UNDER THE DESCRIBED CIRCUMSTANCES, EXISTING LABORATORY PROCEDURES AND CLINICAL DIAGNOSTIC PROCEDURES FURTHER REDUCE THE LIKELIHOOD OF ANY IMPACT ON PATIENT RESULTS. THESE MARKET DO NOT REQUIRE A CORRECTION THROUGH A RECALL. THIS IS JUSTIFIED FROM A RISK-BASED PERSPECTIVE AS THE LIMITED POTENTIAL FOR EXPOSURE DOES NOT SIGNIFICANTLY ALTER THE ESTABLISHED BENEFIT-RISK PROFILE OF THE DEVICE.