ELECSYS T4

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE COBAS E 801 ANALYTICAL UNIT IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS T4 (T4) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 16.9 MG/DL. THIS RESULT WAS DEEMED TOO HIGH FOR THE "PATIENT'S CLINIC". THE FIRST REPEAT RESULT WAS 5.78 MG/DL. THE SECOND REPEAT RESULT WAS 5.46 MG/DL.

Additional Manufacturer Narrative

THE INVESTIGATION NOTED THAT THE INITIAL AND REPEAT RESULTS WERE FROM DIFFERENT REAGENT PACKS. THE FIRST REAGENT PACK WHICH GAVE THE INITIAL QUESTIONABLE RESULT HAD FILM/FOAM/BUBBLES ON THE SURFACE, CAUSING THE PIPETTING OF AN INSUFFICIENT REAGENT VOLUME. THE INVESTIGATION REVIEWED THE CALIBRATION DATA FROM THE SECOND REAGENT PACK; THE RESULTS WERE WITHIN SPECIFICATIONS BUT ON THE LOW SIDE. THE INVESTIGATION REVIEWED THE QC DATA. THE QC DATA OF THE FIRST REAGENT PACK HAD AN ERROR ALARM. THE QC DATA OF THE SECOND REAGENT PACK WERE WITHIN SPECIFICATIONS. THE FIELD SERVICE ENGINEER PERFORMED PREVENTIVE MAINTENANCE ON THE ANALYZER AND REPLACED THE MEASURING CELLS. HE PERFORMED AN INSTRUMENT CHECK WITH SUCCESSFUL RESULTS. A GENERAL REAGENT ISSUE CAN BE EXCLUDED BASED ON THE INFORMATION PROVIDED. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH FILM/FOAM/BUBBLES ON THE REAGENT SURFACE PRODUCT LABELING STATES "AVOID FOAM FORMATION IN ALL REAGENTS AND SAMPLE TYPES (SPECIMENS, CALIBRATORS AND CONTROLS)."