AMMONIA II

Additional Manufacturer Narrative

THE INVESTIGATION RULED OUT A GENERAL REAGENT PROBLEM BECAUSE THE CALIBRATION AND QC WERE ACCEPTABLE. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE ALARM TRACE SHOWED TWO SAMPLE SHORT ALARMS. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE NH3L AMMONIA RESULTS FOR 1 PATIENT EDTA PLASMA SAMPLE ON A COBAS 6000 C501 MODULE. THE INITIAL NH3L RESULT WAS 11.9 UMOL/L. THE DOCTOR QUESTIONED THE RESULT WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED AND THE REPEAT RESULT WAS 42.9 UMOL/L WITH FLAG.