Description of Event or Problem · 1
ROCHE DIAGNOSTICS (A DISTRIBUTOR OF DATA INNOVATIONS' INSTRUMENT MANAGER SOFTWARE) REPORTED AN ISSUE TO DATA INNOVATIONS (DI) ON BEHALF OF (B)(6) ON (B)(6) 2021: AN INITIAL RESULT FOR A FERRITIN TEST WAS RECEIVED FROM THE ROCHE COBAS 8000 ANALYZER WITH A HIGH RESULT FLAG. THE SAMPLE WAS HELD BASED ON A CONFIGURATION SETTING AND THEN RERAN FOR DILUTION. THE SECOND RUN PROVIDED AN ERRONEOUS RESULT, WITH A VALUE OF '2000' AND HIGH FLAG BUT WITH A DILUTION OF X20. AS A RESULT, THE SAMPLE WAS RUN A THIRD TIME ON DILUTION. WHILE THE RERUN WAS RUNNING, THE LAB TECH MANUALLY RELEASED THE ORIGINAL RESULT FROM THE INSTRUMENT WITH A VALUE OF '2000' AND HIGH FLAG. THIS WAS REPORTED AS A CRITICAL/POSITIVE RESULT AND THE PATIENT WAS GIVEN A DIAGNOSIS OF HELPPHAGOCYTIC-LYMPHOHISTIOCYTOSIS (HLS). AS A RESULT, AN INCORRECT DIAGNOSIS WAS DISCUSSED WITH THE FAMILY, A SPECIALIST WAS CONSULTED, AND AN UNSCHEDULED BLOOD DRAW TOOK PLACE. THE FOLLOW-UP TESTING DETERMINED THAT THE RESULT WAS A FALSE POSITIVE. THIS IS NOT A MALFUNCTION OF INSTRUMENT MANAGER. REPORT IS BEING SUBMITTED DUE TO DATA INNOVATIONS BECOMING AWARE THAT THE ERRONEOUS RESULT BEING REPORTED TO THE PATIENT WHICH RESULTED IN A SPECIALIST CONSULTATION AND AN UNSCHEDULED BLOOD DRAW. FDA SAFETY REPORT ID# (B)(4).