ATELLICA CH

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT THE FALSELY DEPRESSED CALCIUM_2 (CA_2) RESULTS WERE OBTAINED ON SEVEN PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. QUALITY CONTROL (QC) AND CALIBRATION RESULTS WERE WITHIN ACCEPTABLE LIMITS PRIOR TO RUNNING THE PATIENT SAMPLES. SIEMENS REMOTELY ASSISTED THE CUSTOMER AND RESEATED, CLEANED DILUTION PROBE, RAN SYSTEM CHECK, ALIGNED DILUTION ARM, SAMPLE PROBE ARM, REAGENT /SAMPLE/DILUTION MIXERS, VERIFIED ALIGNMENTS FOR REAGENT PROBE 1(R1)/ REAGENT PROBE 2(R2) VIA PROBE REPLACEMENT AND PRIMED PROBES FOR 10 TIMES AND RERAN QC, WHICH RECOVERED ACCEPTABLY. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER¿S SITE. DURING THE VISIT, THE CSE PERFORMED SYSTEM CHECK FOR SAMPLE PROBE ROTATION, REPLACED IMPELLER AND PERFORMED SYSTEM CHECK, RESET INSTRUMENT AND PERFORMED PATIENT CORRELATIONS ON 10 PATIENTS ON TWO CHEMISTRY INSTRUMENTS FOR CALCIUM ASSAY, WHICH RECOVERED ACCEPTABLY. SIEMENS IS EVALUATING THE ISSUE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE FALSELY DEPRESSED CALCIUM_2 (CA_2) RESULTS WERE OBTAINED ON SEVEN PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE REPEAT RESULTS MATCHED CLINICAL PICTURE OF THE PATIENTS AND WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CA_2 RESULTS.