DIMENSION® CLINICAL CHEMISTRY SYSTEM

Additional Manufacturer Narrative

SIEMENS HAS CONFIRMED BACTERIAL CONTAMINATION IN CHEMISTRY WASH LOT RD41041. A POSITIVE BIAS WILL BE OBSERVED ON CTNI, LTNI, TSH, PBNP AND LPBN AND A NEGATIVE BIAS WILL BE SEEN ON FT4 WHEN THIS LOT IS FIRST PLACED ON THE INSTRUMENT WITHOUT RECALIBRATION OF METHODS. RECALIBRATION OF THESE ASSAYS WHEN USING THIS LOT WILL NOT CORRECT THE PROBLEM AND MAY CAUSE FALSELY HIGH OR LOW RESULTS. SIEMENS ISSUED AN URGENT MEDICAL DEVICE RECALL DATED JULY 2014, COMMUNICATION #14-48, TO ALL ACCOUNTS WHO HAD RECEIVED THE IMPACTED LOT. CUSTOMERS WERE ADVISED OF THE IMMEDIATE REMEDIAL ACTIONS TO BE TAKEN BY THE CUSTOMER: IMMEDIATELY DISCONTINUE USE AND DISCARD ALL INVENTORY OF CHEMISTRY WASH LOT RD41041. IF THIS LOT WAS NEVER IN USE ON THE INSTRUMENT, NO FURTHER ACTION IS NEEDED. IF THIS LOT HAD BEEN IN USE: PLACE AN ALTERNATE LOT OF CHEMISTRY WASH ON THE DIMENSION SYSTEM. PRIME THE NEW BOTTLE OF CHEMISTRY WASH 30 TIMES. RECALIBRATE THE CTNI, LTNI, TSH, FT4, PBNP AND/OR LPBN ASSAYS USING THE ALTERNATE LOT OF CHEMISTRY WASH ONBOARD. FOR THE LISTED ASSAYS, PROCESS QUALITY CONTROL EVERY 8 HOURS. IN THE URGENT MEDICAL DEVICE RECALL COMMUNICATION IT WAS STATED THAT SIEMENS WAS SHIPPING REPLACEMENT PRODUCT AT NO CHARGE FOR ALL ORDERS FILLED WITH LOT RD41041. AS AN ADDITIONAL PRECAUTION, A SIEMENS CUSTOMER SERVICE ENGINEER WOULD BE MAKING A VISIT TO DECONTAMINATE THE SYSTEM(S) OF CUSTOMERS WHO HAVE USED LOT RD41041. THE CUSTOMER CONFIRMED THAT THEY HAD RECEIVED THE URGENT MEDICAL DEVICE RECALL LETTER. SUBSEQUENTLY, SIEMENS HAD PERFORMED A THOROUGH DECONTAMINATION OF THEIR INSTRUMENT SYSTEM. THE CUSTOMER HAD FAILED TO DISCARD A BOTTLE OF CHEMISTRY WASH LOT RD41041 BUT HAD WRITTEN "DO NOT USE"ON THE BOTTLE LABEL. NEVERTHELESS, THE MARKED BOTTLE WAS PLACED ON THE INSTRUMENT AND CONTAMINATION OCCURED. USER ERROR ALSO INVOLVED THE USE OF THE CHEMISTRY WASH LOT RD41041 AT A DATE BEYOND THE EXPIRATION DATING OF THE LOT. THE EXPIRATION DATE OF LOT RD41041 IS 2014-10-13. THE CONTAMINATION WAS NOTED AND THE BOTTLE REMOVED FROM THE INSTRUMENT SYSTEM ON 2014-10-20. A SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER SERVICE ENGINEER HAS BEEN DISPATCHED TO THE SITE TO PERFORM A REPEAT SYSTEM DECONTAMINATION.

Description of Event or Problem

FALSELY ELEVATED N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) RESULTS WERE OBTAINED ON QC SAMPLES WITH CHEMISTRY WASH LOT RD41041 ON THE DIMENSION INSTRUMENT. NO PATIENT RESULTS WERE REPORTED TO PHYSICIANS WHILE QC WAS OUT OF RANGE. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY ELEVATED PBNP QC RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED PBNP QC RESULTS.