AMMONIA II

Additional Manufacturer Narrative

THE QC RESULTS WERE ACCEPTABLE. THE FIELD SERVICE ENGINEER DID NOT FIND ANY ISSUES. HE CHECKED THE PUMP PRESSURES, ADJUSTED ALL PROBES AND RINSE LEVELS, AND CHECKED THE OUTPUT OF PROBE WASHES AND SAMPLE CLEANER. HE RAN PRECISION TESTING TO VERIFY THE OPERATION OF THE ANALYZER, WHICH WAS ACCEPTABLE. DUE TO THE INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE AMMONIA II RESULTS FROM THE COBAS 6000 C 501 ANALYZER FOR A TOTAL OF SEVEN SAMPLES FROM THREE PATIENTS. THE SAMPLES WERE REPEATED ON ANOTHER ANALYZER. FIVE EXAMPLES WERE PROVIDED. SAMPLE 1 INITIAL RESULT WAS 318.6 UG/DL, AND THE REPEAT RESULTS WERE 28.3 UG/DL AND 28.5 UG/DL. SAMPLE 2 INITIAL RESULT WAS 332.6 UG/DL, AND THE REPEAT RESULT WAS 23.8 UG/DL. SAMPLE 3 INITIAL RESULT WAS 165.1 UG/DL, AND THE REPEAT RESULT WAS 75.8 UG/DL. SAMPLE 4 INITIAL RESULT WAS 212.3 UG/DL, AND THE REPEAT RESULT WAS 31.9 UG/DL. SAMPLE 5 INITIAL RESULT WAS 472.5 UG/DL. THE REPEAT RESULT WITH A 1:2 DILUTION WAS 486.0 UG/DL. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 44.6 UG/DL. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

Additional Manufacturer Narrative

THE COBAS 6000 C 501 SERIAL NUMBER WAS (B)(6). THE CUSTOMER REPLACED THE REAGENT PACK, RECALIBRATED THE ASSAY, AND RAN QC. THE INVESTIGATION IS ONGOING.