DADE ACTIN FSL ACTIVATED PTT REAGENT

Description of Event or Problem

THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED APTT (ACTIVATED PARTIAL THROMBOPLASTIN TIME) SEC RESULT OBTAINED ON A PATIENT SAMPLE MEASURED WITH DADE ACTIN FSL ACTIVATED PTT REAGENT ON THE CS-5100 INSTRUMENT, COMPARED TO REPEAT RESULT. THE FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN WHO DID NOT QUESTION THE RESULT. THE LAB AUTOVERIFIED THE RESULT AND PROVIDED A CORRECTED REPORT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS DISCORDANT RESULTS.

Additional Manufacturer Narrative

AN UNITED STATES (US) CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER TO REPORT A FALSELY ELEVATED APTT (ACTIVATED PARTIAL THROMBOPLASTIN TIME) SEC RESULT THAT WAS OBTAINED ON ONE PATIENT SAMPLE ON THE CS-5100 INSTRUMENT. THE FOLLOWING CONCLUSION IS MADE FROM THE TROUBLESHOOTING PERFORMED BY SIEMENS HEALTHINEERS: BASED ON THE REVIEW OF INFORMATION PROVIDED, THE PROBABLE CAUSE OF THE FALSELY ELEVATED APTT RESULTS USING DADE ACTIN FSL ACTIVATED PTT REAGENT ON THE CS-5100 SYSTEM COULD NOT BE IDENTIFIED. SERVICE ENGINEER CHECKED CUSTOMER SYSTEM, SYSTEM IS OPERATIONAL AND WORKING ACCEPTABLE. THE CUSTOMER IS OPERATIONAL. ASSAY AND INSTRUMENT ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.