DXM 1096 MICROSCAN WALKAWAY INSTRUMENT

Additional Manufacturer Narrative

BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) IS DISPATCHED TO EVALUATE THE DXM 1096 MICROSCAN WALKAWAY INSTRUMENT FOR MISREADS AND IDENTIFY THE FAILURE MODE. SECTION A2, A4, AND A5: INFORMATION NOT PROVIDED BY THE CUSTOMER. THE BECKMAN COULTER INTERNAL IDENTIFIER IS CASE: (B)(4).

Description of Event or Problem

THE CUSTOMER REPORTED THE GENERATION OF HIGH PROBABILITY MISIDENTIFICATION RESULTS USING B1017-219 PC45 PANELS PROCESSED ON THEIR WALKAWAY (WA) SYSTEM (S/N: (B)(6). THE CUSTOMER STATED THAT A PATIENT ISOLATE WAS INITIALLY IDENTIFIED AS S. SHOLIFERI (BIOTYPE 313731, 99.99% PROBABILITY) USING PC45 PANEL, AND THIS IDENTIFICATION WAS REPORTED TO THE PHYSICIAN. REPEAT TESTING USING BIOFIRE AND B1017-166 RPID2 PANEL WAS PERFORMED, AND BOTH GAVE AN IDENTIFICATION OF S. AUREUS. THE UPDATED IDENTIFICATION REPORT WAS PROVIDED TO THE PHYSICIAN, AND THE PHYSICIAN HAD TO CHANGE THE PATIENT'S COURSE OF TREATMENT BASED ON THE AMENDED REPORT WITH THE CORRECT ORGANISM IDENTIFICATION, HOWEVER NO ADDITIONAL DETAILS WERE PROVIDED. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

Description of Event or Problem

THE CUSTOMER REPORTED THE GENERATION OF HIGH PROBABILITY MISIDENTIFICATION RESULTS USING B1017-219 PC45 PANELS PROCESSED ON THEIR DXM WALKAWAY (WA) SYSTEM (S/N (B)(6)) ON (B)(6)2024. THE CUSTOMER STATED THAT A PATIENT ISOLATE WAS INITIALLY IDENTIFIED AS (B)(6) (BIOTYPE 313731, (B)(4) PROBABILITY) USING PC45 PANEL, AND THIS IDENTIFICATION WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER REPEATED TESTING OF THE ISOLATE WITH THE PC45 PANEL AND OBTAINED THE SAME RESULT. THE OFFLINE COAGULASE TEST WAS POSITIVE. FURTHER TESTING USING BIOFIRE AND B1017-166 RPID2 PANEL TYPE WAS PERFORMED, AND BOTH GAVE AN IDENTIFICATION OF (B)(6). THE UPDATED IDENTIFICATION REPORT WAS PROVIDED TO THE PHYSICIAN, AND THE PHYSICIAN HAD TO CHANGE THE PATIENT'S COURSE OF TREATMENT BASED ON THE AMENDED REPORT WITH THE CORRECT ORGANISM IDENTIFICATION, HOWEVER NO ADDITIONAL DETAILS WERE PROVIDED. THERE WAS NO REPORT OF DEATH OR INJURY IN CONNECTION WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

Additional Manufacturer Narrative

BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE DXM 1096 MICROSCAN WALKAWAY INSTRUMENT FOR MISREADS AND FOUND REAGENT WAS DRIPPING FROM THE DISPENSE HEAD DUE TO A FAILED MANIFOLD; NO OTHER INSTRUMENT ISSUES WERE FOUND. THE FSE REPLACED OUT THE FAULTY MANIFOLD TO RESOLVE THE ISSUE. HOWEVER, IT IS UNKNOWN IF THIS LEAKING VALVE HAD AN IMPACT ON THE PANEL IDENTIFICATION, AS REPEAT TESTING WAS NOT PERFORMED FOLLOWING THE REPAIR. ALTHOUGH THE SAMPLE RESULT IS DISCORDANT WITH THREE OTHER METHODS, THE CUSTOMER REPORTED THAT THE ISSUE WAS SPECIFIC TO ONE PATIENT SAMPLE. THE CUSTOMER DID NOT REPORT ANY OTHER ISSUES. DISPENSE ISSUES RESULTING IN REAGENT NOT BEING DISPENSED PROPERLY INTO THE PANEL WELLS CAN IMPACT THE BIOCHEMICAL REACTIONS AND THE ORGANISM IDENTIFICATION. IT IS UNCLEAR IF THE FAILED MANIFOLD AND/OR ATYPICAL BEHAVIOR OF THE ISOLATE CONTRIBUTED TO THE IDENTIFICATION DISCREPANCY. THE FAILURE MODE FOR THE REPORTED MISIDENTIFICATION COULD NOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED. THERE IS NO EVIDENCE OF A SYSTEMIC ISSUE. THERE WAS NO REPORT OF DEATH OR INJURY IN CONNECTION WITH THIS EVENT. THEREFORE, NO FURTHER ACTION IS REQUIRED. SECTION A2, A4, AND A5: INFORMATION NOT PROVIDED BY THE CUSTOMER. THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).