BOND-III AUTOMATED SLIDE STAINER

Description of Event or Problem

ON (B)(6) 2026, A COMPLAINT WAS RAISED AND THE FOLLOWING INFORMATION WAS DOCUMENTED: ¿BOND-III VARIABLE STAINING¿. ON (B)(6) 2026, THE AWARENESS DATE FOR THIS EVENT WAS REVISED TO (B)(6) 2026. ON (B)(6) 2026, THE FOLLOWING PATIENT IMPACT WAS DOCUMENTED: "STAINING FOR CERTAIN MARKERS HAS BEEN INCONSISTENT WITH NO OBVIOUS CAUSE... THIS INCONSISTENT STAINING HAS LED TO PATIENT SAMPLES STAINING IN A DIFFERENT PATTERN THAN EXPECTED BUT HAS BEEN INTERPRETED AS POSITIVE. THIS HAS RESULTED IN A CHANGE OF DIAGNOSIS FOR ONE PATIENT (WHICH WAS RELEASED TO THE PATIENT BEFORE SUPPLEMENTARY TESTING PROVED DIFFERENT ¿ GENETIC TESTING). VARIABLE STAINING WAS NOT SEEN IN OPTIMISATION OR VALIDATION. CLINICAL IMPACT STATEMENT FROM CLINICAL IMPACT LEAD (NEUROPATHOLOGIST): IN THESE 3 CASES THESE GLIOMAS HAVE BEEN INTERPRETED AS REPRESENTING IDH1 MUTATED TISSUE. IN 2 OF THESE CASES, IT HAS BEEN INTERPRETED AS A LOW-GRADE GLIOMA NAMELY AN ASTROCYTOMA WHICH CAN BE A LOW- OR HIGH-GRADE LESION. GENETICS HAS CLARIFIED THE ENTITIES IN ALL 3 CASES, BUT THIS ONE DOES MEAN THERE HAS BEEN A DELAY IN TREATMENT MAKING DECISIONS. IN THE CASE OF (B)(6) ESSENTIALLY BENIGN TISSUE HAS BEEN INTERPRETED AS TUMOUR BECAUSE OF THIS. RADIOLOGICALLY THEY HAVE A TUMOUR, AND IT MIGHT BE THAT THE BIOPSY HAS MISSED THIS, SO WE ARE NOW SUBMITTING FROZEN TISSUE FOR CLARIFICATION. THIS DOES REPRESENT A DELAY OF A MONTH. IN THE CASE OF (B)(6) THIS WAS DIAGNOSED HIGH GRADE AND REMAINED HIGH GRADE SO NO CHANGE IN TREATMENT OR PROGNOSIS. IN (B)(6) IT WAS DIAGNOSED AS LOW GRADE AND MOLECULAR CORRECTLY CHARACTERISED AS A HIGH GRADE." SEE REPORT 8020030-2026-00011 FOR THE SUBMISSION FOR PATIENT (B)(6). AS THERE WAS NO IMPACT TO PATIENT (B)(6), THERE IS NO SUBMISSION FOR THIS PATIENT.

Additional Manufacturer Narrative

THE ROOT CAUSE FOR THE VARIABLE STAINING REPORTED BY THE CUSTOMER COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. LACK OF RE-CALIBRATION AFTER MOVING THE INSTRUMENT, PROBLEMS WITH THE IDH1 ANTIBODY CLONE OR SUPPLIER CHANGES AND DIFFICULTY INTERPRETING RESULTS DUE TO ABERRANT OR ARTEFACTUAL STAINING MAY HAVE CONTRIBUTED TO THIS EVENT. MANUFACTURER EVALUATION OF THE INFORMATION AVAILABLE SHOWED THAT THE INSTRUMENT FUNCTIONED AS DESIGNED, DURING THE EXECUTION OF THE AFFECTED SLIDE STAINING RUN(S).