REMISOL

Description of Event or Problem

THE CUSTOMER REPORTED AN ISSUE INVOLVING THE REMISOL. INCORRECT RESULTS FOR HEPATITIS A VIRUS ANTIBODY (HAV_AB) WERE SENT TO THE LABORATORY INFORMATION MANAGEMENT SYSTEM (LIMS) DUE TO A RULES CONFIGURATION. THE RESULT WAS REPORTED AS '<35' INSTEAD OF THE CORRECT VALUE FROM THE LIAISON INSTRUMENT. AS A RESULT, THE PATIENT WAS TREATED AS HEPATITIS A-POSITIVE. ONCE THE ISSUE WAS IDENTIFIED, THE RESULT WAS CORRECTED IN THE PATIENT¿S CHART.

Additional Manufacturer Narrative

THERE WAS NO FURTHER INFORMATION PROVIDED REGARDING THE PATIENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE REMISOL. THE PROBABLE CAUSE OF THE ISSUE WAS IDENTIFIED AS AN ACTIVE RULE IN REMISOL CONFIGURED FOR THE ACCESS2 TEST HAV_AB, WHICH WAS NOT UPDATED AFTER SWITCHING TO THE LIAISON INSTRUMENT. THE RULE INTERPRETED RESULTS BELOW A THRESHOLD AS POSITIVE AFTER A SWITCH FROM ACCESS2 TO LIAISON ANALYZER. THE FAS DISABLED THE RULE IN QUESTION WITHIN THE REMISOL SYSTEM TO RESOLVE THE ISSUE. THE RESULT IN LIMS WAS CORRECTED AND REPORTED. THERE WAS NO EVIDENCE OF REMISOL SYSTEM OR SOFTWARE MALFUNCTION. SECTION A2, A3, A4, A5 AND A6: INFORMATION NOT PROVIDED BY CUSTOMER. SECTION E1, INITIAL REPORTER TELEPHONE NUMBER IS -(B)(6). SECTION G1, REPORTING CONTACT TELEPHONE NUMBER IS (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).