ELECSYS IGE II

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER REPLACED THE PINCH VALVES. ON HIS SECOND SERVICE VISIT, HE PERFORMED MECHANICAL AND INSTRUMENT CHECKS. THE INVESTIGATION NOTED THAT THE CUSTOMER DOES NOT USE RACK ADAPTERS FOR THE 13 MM SAMPLE TUBES. PRODUCT LABELING STATES "INSERTING A ROCHE RACK CUP ADAPTER INTO A RACK - USE ROCHE RACK CUP ADAPTERS TO IMPROVE THE ALIGNMENT OF 13 MM TUBES. WARNING ! INCORRECT RESULTS AND ERRORS DUE TO MISALIGNED SAMPLE TUBES NOT USING A ROCHE RACK CUP ADAPTER WITH 13 MM TUBES OR INCORRECT USE OF A ROCHE RACK CUP ADAPTER MAY CAUSE INCORRECT RESULTS OR ERRORS. ALWAYS USE ROCHE RACK CUP ADAPTERS WITH 13 MM TUBES. ENSURE THAT SAMPLE TUBES ARE STRAIGHT." THE INVESTIGATION REVIEWED THE CALIBRATION DATA AND NOTED THAT THE CALIBRATION SIGNALS MAY BE LOWER THAN EXPECTED. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS E411 DISK IS (B)(6). THE FIELD SERVICE ENGINEER PERFORMED PREVENTIVE MAINTENANCE ON THE ANALYZER. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS IGE II RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E411 DISK. THE INITIAL RESULT WAS 405.1 NG/ML. THE REPEAT RESULT WAS 253.2 NG/ML.