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Patient 1
SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED THE ADVIA? CHEMISTRY TRIGLYCERIDE CONCENTRATED REAGENT (TRIG_C) DOES NOT MEET INSTRUCTIONS FOR USE (IFU) LINEARITY CLAIM AT THE UPPER LIMIT OF THE ASSAY RANGE AS IT APPROACHES END OF SHELF LIFE FOR KIT LOT 365096. INTERNAL TESTING INDICATES THAT A PATIENT BIAS (-7% TO -12%) MAY BE SEEN AT CONCENTRATION LEVELS FROM 550 TO 600 MG/DL (6.22 TO 6.78 MMOL/L). LINEARITY IS REDUCED BY APPROXIMATELY 50% AT TRIGLYCERIDE CONCENTRATIONS APPROACHING THE UPPER END OF THE EXTENDED RANGE OF 1100 MG/DL (12.43 MMOL/L). QUALITY CONTROL (QC) MATERIAL MAY NOT DETECT THIS ISSUE DEPENDING ON THE TRIGLYCERIDE CONCENTRATIONS IN THE QC MATERIAL. SIEMENS INTERNAL TESTING HAS CONFIRMED ALL OTHER IN DATE LOTS ARE CURRENTLY MEETING LINEARITY IFU CLAIMS. HOWEVER, AS A PRECAUTION, UNTIL ROOT CAUSE IS DETERMINED, A SHORT TERM MITIGATION OF REDUCING THE EXPIRATION DATE TO 6 MONTHS FOR ALL LOTS OF ADVIA CHEMISTRY SYSTEMS TRIGLYCERIDE CONCENTRATED HAS BEEN IMPLEMENTED. AN URGENT FIELD SAFETY NOTICE (UFSN) CHC16-03A.A.OUS WAS SENT TO OUS CUSTOMERS AND A URGENT MEDICAL DEVICE RECALL (UMDR) CHC16-03A.A.US WAS SENT TO US CUSTOMERS IN AUGUST OF 2016. THE UFSN AND UMDR STATE THAT CUSTOMERS ARE TO DISCONTINUE USE AND DISCARD REAGENT KIT LOT 365096.