DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

Description of Event or Problem

BIASED LOW ENZYMATIC CREATININE (WCRE) RESULTS WERE OBTAINED ON QC SAMPLES AT ONE DAY AFTER CALIBRATION. THE BIAS WAS DISCOVERED DURING A LABORATORY STUDY TO SEE IF THE WCRE REAGENT WOULD BE IMPACTED IN THE SAME MANNER AS THE SIEMENS EZCR METHOD DUE TO INTERACTION WITH THE SIEMENS PHOS FLEX REAGENT CARTRIDGE REAGENT. PATIENT RESULTS WERE NOT REPORTED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF BIASED LOW WCRE RESULTS DURING THE LABORATORY STUDY. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE BIASED LOW WCRE RESULTS.

Additional Manufacturer Narrative

ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA ASSOCIATED WITH THE LABORATORY STUDY INDICATE THAT THE CAUSE FOR THE BIASED LOW WCRE QC RESULTS IS AN INTERACTION BETWEEN THE SIEMENS PHOS REAGENT CARTRIDGE AND THE WAKO WCRE ENZYMATIC CREATININE REAGENT CARTRIDGES WHICH WERE BEING STORED ON THE SAME INSTRUMENTS. IN (B)(6), WAKO FILLS AN ENZYMATIC CREATININE REAGENT INTO FLEXES (WCRE) AND SELLS THIS PRODUCT EXCLUSIVELY IN (B)(6). LOADING A FULLY OPENED PHOS FLEX AND AN OPENED WCRE FLEX ON AN EMPTY DIMENSION SYSTEM AND LETTING THE SYSTEM SIT IDLE OVERNIGHT PRODUCES DEPRESSED WCRE RESULTS AT A SIMILAR MANNER TO WHAT WAS PREVIOUSLY OBSERVED WITH THE SIEMENS EZCR FLEX REAGENT CARTRIDGE. SIEMENS HEALTHCARE DIAGNOSTICS INC. HAD PREVIOUSLY CONFIRMED CUSTOMER COMPLAINTS OF FALSELY DEPRESSED ENZYMATIC CREATININE (EZCR) RESULTS WHEN EZCR IS PROCESSED FROM OPEN WELLS OF ENZYMATIC CREATININE (EZCR) FLEX® REAGENT CARTRIDGES THAT ARE IN CLOSE PROXIMITY TO OPEN WELLS OF PHOSPHORUS (PHOS) FLEX® REAGENT CARTRIDGES. THE FALSELY DEPRESSED EZCR RESULTS ARE CAUSED BY A EZCR REAGENT INTERACTION WITH VAPORS EMITTED FROM THE PHOS REAGENT. SIEMENS (B)(6) PERFORMED AN INTERNAL STUDY THAT INDICATES THE WAKO ENZYMATIC CREATININE METHOD (WCRE) IS AFFECTED BY THE DIMENSION PHOSPHOROUS REAGENT (PHOS) IN THE SAME MANNER. THIS ISSUE IS LINKED TO THE SIEMENS FIELD ACTION DC 13-04, EVEN THOUGH THE WAKO CREATININE IS NOT A SIEMENS METHOD. AN URGENT MEDICAL DEVICE CORRECTION FOR THE PHOS FLEX® REAGENT CARTRIDGE (DF61), COMMUNICATION #(B)(4) WAS ISSUED IN FEBRUARY 2013 TO IMPACTED CUSTOMERS. THE COMMUNICATION PROVIDED REMEDIAL ACTIONS TO CUSTOMERS TO EITHER RUN PHOS AND EZCR ON SEPARATE DIMENSION SYSTEMS IF THE CUSTOMER HAS MORE THAN ONE DIMENSION SYSTEM OR TO DISCONTINUE THE USE OF EITHER PHOS OR EZCR ON THEIR DIMENSION® SYSTEM. AN URGENT FIELD SAFETY NOTICE FOLLOW-UP LETTER FOR WAKO WCRE ((B)(4)), COMMUNICATION 14-27 HAS BEEN ISSUED IN MAY 2014 TO IMPACTED (B)(6) CUSTOMERS ONLY. THE LETTER INFORMED THE IMPACTED (B)(6) CUSTOMERS THAT SIEMENS HAS NOW CONFIRMED FALSELY DEPRESSED CREATININE RESULTS WHEN WCRE IS PROCESSED FROM OPEN WELLS THAT ARE IN CLOSE PROXIMITY TO OPEN WELLS OF PHOS REAGENT. THE COMMUNICATION PROVIDED REMEDIAL ACTIONS TO CUSTOMERS TO EITHER RUN PHOS AND WCRE ON SEPARATE DIMENSION SYSTEMS IF THE CUSTOMER HAS MORE THAN ONE DIMENSION SYSTEM OR TO DISCONTINUE THE USE OF EITHER PHOS OR WCRE ON THEIR DIMENSION® SYSTEM.