CELL-DYN SMS

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

Description of Event or Problem

THE CUSTOMER REPORTS THAT THE CELL-DYN SLIDE MAKER STAINER (SMS) INSTRUMENT ASSIGNED THE INCORRECT PATIENT IDENTIFICATION TO A PREPARED BLOOD SAMPLE FILM. THE ISSUE COULD NOT BE RECREATED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

INSTRUMENT LOG FILES FROM THE CELL-DYN SMS (SLIDE MAKER STAINER) WERE NOT AVAILABLE FROM THE CUSTOMER SITE. FROM INFORMATION GATHERED FROM THE CUSTOMER, THE INSTRUMENT EXPERIENCED AN ISSUE IN ITS DISPENSING/RINSING CIRCUIT CAUSING SOME BLOOD FROM THE FIRST SAMPLE TO REMAIN IN THE ASPIRATION TUBING. IT IS REASONED THAT A SMALL AMOUNT OF AIR WAS BLOCKING THE TUBING AND A PORTION OF THE FIRST SAMPLE REMAINED IN THE TUBING AND WAS NOT DISPENSED ONTO THE FIRST SLIDE. THE REMAINING BLOOD WAS DILUTED WITH DILUENT DURING THE RINSING PROCESS. THIS CAUSED THE NEXT SAMPLE ASPIRATION TO BE NEGATIVELY AFFECTED BECAUSE THE SENSOR DETECTED THE PRESENCE OF THE REMAINING SAMPLE IN THE ASPIRATION CIRCUIT. WHEN THE DISPENSE CYCLE FOR THE SECOND SAMPLE WAS PERFORMED, THE DILUTED FIRST SAMPLE WAS ADDED TO THE SECOND SLIDE. THE CUSTOMER COULD NOT TELL IF THE BLOOD SMEAR OF THE SECOND SLIDE IS A MIXTURE OF THE FIRST AND SECOND SAMPLES. THE RESULTS OF THE REVIEW OF THE SECOND SLIDE WERE NOT PROVIDED. A POSITIVE IDENTIFICATION COULD NOT BE DETERMINED. AN ABBOTT FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND COULD NOT REPRODUCE THE ISSUE. HOWEVER, AS A PREVENTIVE MEASURE, SEVERAL INSTRUMENT PARTS WERE EITHER CLEANED OR REPLACED. SUBSEQUENT INSTRUMENT OPERATIONS WERE ACCEPTABLE. NO FURTHER ISSUES WERE NOTED. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE CELL-DYN SMS OPERATION MANUAL CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. THIS ISSUE WAS SPECIFIC TO THE INDIVIDUAL CELL-DYN SMS INSTRUMENT AT THIS SPECIFIC CUSTOMER SITE. BASED ON THE EVALUATION RESULTS AND THE INFORMATION FROM THE CUSTOMER SITE, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT DEFICIENCY IS PRESENT. THE ISSUE WAS ADDRESSED THROUGH STANDARD TROUBLESHOOTING PROCEDURES.