STATSENSOR CREATININE STRIP

Description of Event or Problem

RADIOLOGICAL TECH ALERTED LABORATORY THAT RESULTS FROM NOVA STATSENSOR METER GREATLY DIFFERED FROM CHEMISTRY CREATININE RESULTS PERFORMED IN THE LABORATORY. METER WAS IMMEDIATELY PULLED FROM SERVICE. LABORATORY RAN QC AND LINEARITY WHICH HAD ACCEPTABLE RESULTS. A CORRELATION STUDY WAS PERFORMED WITH ERRATIC AND QUESTIONABLE RESULTS. THE METER WAS REPLACED BY NOVABIOMEDICAL. QC AND LINEARITY WERE AGAIN ACCEPTABLE BUT CORRELATION STUDY WAS ERRATIC AS WELL. CALLED THE NOVA HOT LINE AND WAS ADVISED TO USE A NEWER STRIP LOT. QC AND LINEARITY STUDY WAS PERFORMED WITH NEW METER AND NEW STRIP LOT. RESULTS WERE AGAIN ACCEPTABLE, HOWEVER, THE CORRELATION STUDY WAS STILL ERRATIC. NOVABIOMEDICAL SENT THEIR APPLICATION SPECIALIST TO REPEAT THESE STUDIES. HIS RESULTS CONCURRED WITH THE EARLIER STUDIES. THE APPLICATION SPECIALIST FROM NOVABIOMEDICAL STATED THE ISSUE IS WITH THE STRIPS LOT AS THE APPLICATION SPECIALIST ADVISED HER THAT AN OFFSET SHOULD BE PROGRAMMED INTO THE METERS EACH TIME A LOT NUMBER CHANGE OCCURS. HE ADVISED THAT CORRELATION STUDY MUST BE DONE FOR EACH NEW STRIP LOT AS THE OFFSET WILL CHANGE FROM LOT TO LOT. AFTER THE APPLICATION SPECIALIST PROGRAMMED THE OFFSET INTO THE METER, THE CORRELATION STUDIES RESULTS WERE STILL ERRATIC. ON PROFICIENCY TESTING, SEVERAL EVENT RESULTS RETURNED WITH "NO CONSENSUS" MEANING THAT RESULTS WERE SO ERRATIC THAT A RANGE CANNOT BE ESTABLISHED WITHIN THE PEER GROUP.======================MANUFACTURER RESPONSE FOR NOVABIOMEDICAL STATSENSOR CREATININE STRIP, NOVABIOMEDICAL STATSENSOR (PER SITE REPORTER).======================NOVABIOMEDICAL SENT IN THEIR APPLICATION SPECIALIST FOR TESTING.======================MANUFACTURER RESPONSE FOR STATSENSOR CREATININE METER, NOVABIOMEDICAL (PER SITE REPORTER).======================NOVABIMOEDICAL SENT IN A NEW METER WHICH PROVIDED THE SAME RESULTS.