ADVIA WORKCELL

Additional Manufacturer Narrative

AN OUTSIDE THE UNITED STATED CUSTOMER CONTACTED SIEMENS TO REPORT THAT TWO PATIENT SAMPLES WERE DROPPED BY THE ADVIA WORKCELL LABORATORY AUTOMATION SYSTEM (LAS) DECAPPER MODULE ONTO THE AUTOMATION TRACK AND LABORATORY FLOOR. NEW SAMPLES WERE ORDERED FROM THE PATIENTS. THE DECAPPER MODULE WAS TAKEN OFF LINE. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE TO INSPECT THE DECAPPER. SIEMENS IS INVESTIGATING.

Description of Event or Problem

TWO PATIENT SAMPLES WERE DROPPED BY THE ADVIA WORKCELL LABORATORY AUTOMATION SYSTEM (LAS) DECAPPER MODULE ONTO THE AUTOMATION TRACK AND LABORATORY FLOOR. THERE WAS INSUFFCIENT SAMPLE FOR TESTING. THE PATIENTS WOULD NEED TO HAVE A NEW SAMPLE DRAWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

Additional Manufacturer Narrative

THE INITIAL MDR WAS SUBMITTED ON 21-SEP-2022. ADDITIONAL INFORMATION (06-OCT-2022): THE SIEMENS CUSTOMER SERVICE ENGINEER (CSE) REPLACED THE DECAPPER GRIPPER PADS AND TESTED THE DECAPPER FUNCTIONALITY. TESTING REVEALED THAT TUBES WERE STILL BEING PULLED FROM PUCKS. THE CSE THEN REPLACED THE SOLENOID VALVE BANK ASSEMBLY AND RETESTED THE DEVICE. THE CSE OBSERVED THAT THE GRIPPER WAS NOT HOLDING THE TUBES TIGHTLY ENOUGH TO ALLOW FOR DECAPPING. THE CSE THEN REPLACED THE TUBE GRIPPER AND SENSOR PNEUMATIC CYLINDER ASSEMBLY AND A CHECK VALVE LOCATED AT THE PNEUMATIC OUTLET FROM SOLENOID BANK. THE CSE CHECKED THE ALIGNMENTS OF THE DECAPPER AND THE OPERATION OF ALL THE SENSORS. THE CSE TESTED THE DECAPPER USING A MANUAL OPERATION MODE AND SUCCESSFULLY DECAPPED 100 TUBES IN THE ROUTINE OPERATIONAL MODE. THE CAUSE OF THE ADVIA WORKCELL LABORATORY AUTOMATION SYSTEM (LAS) DECAPPER MODULE DROPPING TUBES ONTO THE AUTOMATION TRACK AND LABORATORY FLOOR IS UNKNOWN. THE ANALYZER IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THIS ANALYZER IS NEEDED. SECTION H6. ADVERSE EVENT PROBLEM CODE(S) WERE UPDATED.