ATELLICA CH CREATININE_2

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS SIXTY-THREE (63) ERRONEOUSLY ELEVATED PATIENT SAMPLE RESULTS WITH OPEN CHANNEL CREATININE_2 (XUCREA) WERE OBTAINED ON AN ATELLICA CH 930 ANALYZER. SOME OF THE ERRONEOUSLY ELEVATED PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. SOME SAMPLES WERE ALSO TESTED FOR TROUBLESHOOTING PURPOSES ONLY WITH NEW REAGENT USING OPEN CHANNEL XUCREA3. LOWER RESULTS WERE OBTAINED AND CONSIDERED CORRECT. THE OPEN CHANNEL CREATININE_2 (XUCREA) RESULTS FROM THE ALTERNATE ATELLICA CH 930 ANALYZER WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED OPEN CHANNEL CREATININE_2 (XUCREA) RESULTS.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER (CCC) REGARDING ERRONEOUSLY ELEVATED PATIENT SAMPLE RESULTS WITH OPEN CHANNEL CREATININE_2 (XUCREA) USING THE ATELLICA CH CREATININE_2 (CREA_2) REAGENT ON AN ATELLICA CH 930 ANALYZER. SIEMENS HEALTHCARE DIAGNOSTICS SERVICE OPERATIONS SUPPORT (SOS) TEAM CONCLUDED THE INVESTIGATION OF THE EVENT. QUALITY CONTROL (QC) RECOVERY WAS OUTSIDE THE CUSTOMER'S EXPECTED RANGES. IT WAS DISCOVERED THAT A MISLABELED CALIBRATOR HAD BEEN USED FOR THE LOT CALIBRATION. THE CAUSE OF THE EVENT IS CONSISTENT WITH THE USE OF A MISLABELED CALIBRATOR TUBE TO GENERATE A LOT CALIBRATION WHICH WAS ACCEPTED WITH QC OUTSIDE OF CUSTOMER RANGES. THE COMPLAINT IS RESOLVED WITH STANDARD TROUBLESHOOTING BY PERFORMING A NEW LOT CALIBRATION AND OBTAINING ACCEPTABLE QC RESULTS. NO REAGENT NOR INSTRUMENT ISSUES WERE IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED.