STAT PROFILE CRITICAL CARE XPRESS

Description of Event or Problem

PER THE CUSTOMER, A PATIENT WHOLE BLOOD SAMPLES THAT WERE ANALYZED ON A SPECIFIC CRITICAL CARE XPRESS ANALYZER WERE RECOVERING IONIZED CALCIUM RESULTS THAT WERE CLINICALLY SIGNIFICANTLY LOWER THAN OTHER CRITICAL CARE XPRESS ANALYZERS WITHIN THE SAME LABORATORY. RESULT COMPARISON: AFFECTED ANALYZER: 0.62; OTHER ANALYZER IN LAB: 1.22; AFFECTED ANALYZER: 0.57; OTHER ANALYZER IN LAB: 1.24; AFFECTED ANALYZER: 0.58, OTHER ANALYZER IN LAB: 1.18. QUALITY CONTROL RESULTS ON APPLICABLE ANALYZERS WERE IN COMPLIANCE. THE PATIENT'S RESULTS WERE REPORTED BUT NO ACTION WAS DONE FOR PATIENT BASED ON THE RESULTS. A SUPPORT CALL WAS PERFORMED ON THE AFFECTED ANALYZER WHICH INCLUDED REPLACEMENT OF THE IONIZED CALCIUM SENSOR. ALL COMPARISONS WERE ACCEPTABLE. THE CALCIUM SENSOR FROM THE AFFECTED ANALYZER WAS RETURNED TO NOVA BIOMEDICAL FOR INVESTIGATION. THE INVESTIGATION DID NOT CONFIRM THE COMPLAINT OF LOW WHOLE BLOOD CALCIUM RESULTS. AS OF (B)(4) 2011, THERE HAVE BEEN NO FURTHER REPORTS FROM THE CUSTOMER FOR LOW CALCIUM RESULTS SINCE THE SUPPORT CALL.