DXM 1040 MICROSCAN WALKAWAY

Additional Manufacturer Narrative

THE CAUSE OF DEATH IS UNKNOWN. THE INFORMATION AVAILABLE SUGGESTS THE MICROSCAN SYSTEM FAILED TO IDENTIFY THE ORGANISM CORRECTLY BASED ON THE ATYPICAL BEHAVIOR OF THE ISOLATE ITSELF AND NEGATIVE LYS REACTION, WHICH IS A KEY BIOCHEMICAL REACTION USED BY THE SYSTEM TO IDENTIFY AN E. COLI. AS INSTRUMENT AND PANEL QUALITY CONTROL TESTING WERE ALL IN RANGE, A PRODUCT PERFORMANCE ISSUE OR MALFUNCTION IS NOT INDICATED. PANEL DATA DID NOT INDICATE AN OBVIOUS INSTRUMENT OR PANEL ISSUE AND CONFIRMED THE ATYPICAL BEHAVIOR OF THE SAMPLE. THEREFORE, THE PROBABLE CAUSE OF THE REPORTED ORGANISM MISIDENTIFICATION WAS AN ATYPICAL ISOLATE. SECTION A4 AND A5: INFORMATION NOT PROVIDED BY THE CUSTOMER. THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

Description of Event or Problem

THE CUSTOMER REPORTED GETTING HIGH PROBABILITY MISIDENTIFICATION (HPID) OF CITROBACTER FARMERI ON PATIENT SAMPLES USING NEG URINE COMBO 90 (NUC90, P/N C48640, LOT # 2025-11-11) PANELS PROCESSED IN THEIR DXM 1040 MICROSCAN WALKAWAY INSTRUMENT S/N (B)(6). THE CUSTOMER STATED THE MISIDENTIFICATION IMPACTED ONE PATIENT SAMPLE, MULTIPLE CULTURES. THE CUSTOMER NOTIFIED THE PHYSICIAN OF THE ERRONEOUS RESULTS OBTAINED FROM URINE SAMPLE. THE CUSTOMER STATED THE PATIENT WAS PUT ON HOSPICE AND PASSED AWAY ON (B)(6) 2025. IT WAS FURTHER NOTED THAT THE PATIENT DID NOT HAVE CAPACITY AND WAS REFUSING TREATMENT. THE PATIENT¿S FAMILY OPTED FOR COMFORT FOCUSED MEASURES. THE CUSTOMER INDICATED THEY REACHED OUT TO THEIR INTERNAL TEAM, AND THEY STATED THE MISIDENTIFICATION CAUSED A DELAY IN APPROPRIATE TREATMENT FOR THE PATIENT.