ATELLICA CH LACTACTE (LAC)

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT THAT FALSELY DEPRESSED LACTATE (LAC) RESULTS WERE OBTAINED ON FOURTEEN (14) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE CUSTOMER STATED THAT QUALITY CONTROL (QC) RESULTED LOW FOR BOTH LEVELS WHEN THE NEW REAGENT PACK WAS INTRODUCED. SIEMENS IS INVESTIGATING THIS ISSUE.

Description of Event or Problem

DISCORDANT, FALSELY DEPRESSED LACTATE (LAC) RESULTS WERE OBTAINED ON FOURTEEN (14) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE INITIAL DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) BUT IT IS UNKNOWN IF THE RESULTS WERE QUESTIONED. REPEAT TESTING WAS NOT PERFORMED. THE CUSTOMER STATED THAT QUALITY CONTROL (QC) RESULTED LOW FOR BOTH LEVELS WHEN THE NEW REAGENT PACK WAS INTRODUCED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED LAC RESULTS.

Additional Manufacturer Narrative

SIEMENS FILED INITIAL MDR 2432235-2020-00369 ON 20-AUG-2020. CORRECTED INFORMATION (24-AUG-2020): IT WAS CLARIFIED THAT THE DATE OF EVENT WAS (B)(6) 2020, AND NOT (B)(6) 2020, AS INDICATED IN THE INITIAL MDR. SECTION B3 WAS UPDATED TO REFLECT THIS INFORMATION. CLARIFICATION WAS PROVIDED REGARDING THE INITIAL RESULTS THAT WERE REPORTED FOR THE IMPACTED SAMPLES: INITIAL RESULTS WERE REPORTED AS 0.10 MMOL/L. IN THE INITIAL MDR, THE SERIAL NUMBER IN SECTION D WAS INADVERTENTLY FILLED OUT AND THE UNIQUE IDENTIFIER (UDI) # SHOULD BE (B)(4). SECTION D4 WAS UPDATED TO REFLECT THE CORRECTED INFORMATION. ADDITIONAL INFORMATION (24-AUG-2020): THE CUSTOMER REPORTED THAT THE PHYSICIAN(S) DID NOT QUESTION THE INITIALLY REPORTED RESULTS. THE CUSTOMER INDICATED THAT SAMPLES WERE REPEATED; THE REPEAT RESULTS WERE NOT REPORTED DUE TO THE SPECIMEN STABILITY. THEIR LAB POLICY IS TO PROCESS PATIENT SAMPLES FOR LACTIC ACID WITHIN 30 MINUTES OF SPECIMEN TUBE DRAW. SIEMENS FURTHER INVESTIGATED THE EVENT AND DETERMINED THAT THE INSTRUMENT HEALTH REPORT WAS NOT AVAILABLE FOR FURTHER INVESTIGATION. SIEMENS DETERMINED THAT THE INSTRUMENT AND REAGENT WERE PERFORMING ACCORDING TO SPECIFICATIONS AT THE TIME OF THE EVENT. THE CUSTOMER INDICATED THAT THEY DID NOT PREPARE THE REAGENT CORRECTLY AND SIEMENS DETERMINE THAT THIS USE ERROR POTENTIALLY CONTRIBUTED TO THE DISCORDANT, FALSELY DEPRESSED LACTATE RESULTS. THE ISSUE WAS RESOLVED BY PREPARING A NEW REAGENT WELL. QUALITY CONTROLS AND PATIENT SAMPLES WERE SUCCESSFULLY PROCESSED AFTER THE CUSTOMER PREPARED A NEW REAGENT WELL. THE RESULT (INVESTIGATION FINDINGS) CODE AND CONCLUSION (INVESTIGATION CONCLUSIONS) CODE IN SECTION H6 WERE UPDATED TO REFLECT THE ADDITIONAL INFORMATION. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.