TG G2 ELECSYS

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ROCHE DIAGNOSTICS ELECSYS TG II RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL TG RESULT WAS 1.28 NG/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS >500 NG/ML. A 1:10 DILUTION WAS MADE OF THE SAMPLE AND REPEATED AND THE RESULT WAS 954.3 NG/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

Additional Manufacturer Narrative

THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. BASED ON THE CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH PRE-ANALYTICAL SAMPLE HANDLING ISSUES.