AMMONIA II

Additional Manufacturer Narrative

THE AMMONIA II REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE C702 MODULE SERIAL NUMBER WAS (B)(6). THE QC WAS WITHIN THE ASSIGNED RANGES ON THE DAY OF THE EVENT. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE LOW RESULTS FOR 1 PATIENT SAMPLE TESTED WITH AMMONIA II ASSAY ON A COBAS 8000 C702 MODULE. INITIAL RESULT: 1361 UG/DL (TESTED WITH NORMAL MODE AND ACCOMPANIED BY A DATA FLAG). THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT WAS A VERY LOW NEGATIVE RESULT AND REPEATED THE SAMPLE USING DIFFERENT DILUTION FACTORS IN A DECREASE MODE: 1ST REPEAT RESULT: 1700 UG/DL (USING A DILUTION FACTOR 1:2). 2ND REPEAT RESULT: 300 UG/DL (USING A DILUTION FACTOR 1:50). THE SAMPLE WAS THEN REPEATED ON A DIFFERENT C702 MODULE IN ANOTHER SITE AND THE 4TH REPEAT RESULT WAS -600 UG/DL.

Additional Manufacturer Narrative

AFTER THE INITIAL TEST, THE PATIENT WAS TESTED DAILY FOR 1 WEEK; A NEW SAMPLE WAS OBTAINED EACH DAY. THE RESULTS CONSISTENTLY SHOWED AMMONIA II RESULTS OF APPROXIMATELY [-] 1000 UG/DL ON VARIOUS UNSPECIFIED MODULES. TESTING WAS PERFORMED AT ANOTHER HOSPITAL USING A C702 MODULE WITH SIMILAR RESULTS. THE SPECIFIC RESULTS WERE NOT PROVIDED.