AU5800 CLINICAL CHEMISTRY ANALYZER

Additional Manufacturer Narrative

(B)(6). NOTE: BECKMAN COULTER IS CONDUCTING A RETROSPECTIVE REVIEW OF ITS GLOBAL SERVICE RECORDS, TO ENSURE THAT THE RECORDS HAD BEEN ADEQUATELY EVALUATED FOR POTENTIAL COMPLAINT INFORMATION AND ANY WARRANTED FOLLOW-UP ACTION, INCLUDING MDR REPORTING. THIS MDR REPORT IS A RESULT OF THAT RETROSPECTIVE REVIEW. MANUFACTURING INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE AU5800 CLINICAL CHEMISTRY ANALYZER WAS EVALUATED AT THE USER FACILITY BY A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE). INSTRUMENT FUNCTIONAL CHECKS WERE PERFORMED WHICH IDENTIFIED ERRONEOUS RESULTS. THE SERVICE DOCUMENTATION REVEALED THAT THE FSE REPLACED THE PERSTATIC PUMP TUBE, CLEANED THE TUBING AND CALIBRATED THE ELECTRODE. FOLLOWING THE SERVICE ACTIVITY, THE INSTRUMENT WAS RESTORED TO FULL FUNCTIONALITY. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS ABLE TO CONFIRM THE FAILURE MODE. THE FSE IDENTIFIED A PERSTALTIC PUMP TUBE ISSUE, CLEANED TUBING AND CLAIBRATED ELECTRODE WHICH ATTRIBUTED TO THE REPORTED EVENT. THEREFORE, THE COMPLAINT EVENT WAS CONFIRMED.

Description of Event or Problem

THE COMPLAINANT REPORTED THAT THE INSTRUMENT EXPERIENCED PROBLEMS WITH ION-SELECTIVE ELECTRODE (ISE) CALIBRATION, INACCURATE OR ERRONEOUS RESULTS. THERE WAS NO REPORT OF PATIENT RESULTS RELEASED FROM THE LABORATORY. NO PATIENT CONSEQUENCES OR ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS EVENT. NO CALIBRATION DATA WAS SUPPLIED FOR THIS INCIDENT. THE COMPLAINT DEVICE WAS AVAILABLE FOR EVALUATION.