ATELLICA CH TACROLIMUS (TACR)

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT AN ABOVE ASSAY RANGE RESULT FOR TACROLIMUS (TACR) ON A PATIENT SAMPLE WHEN PROCESSED ON AN ATELLICA CH 930 INSTRUMENT (S/N CM03641) WITH REPEAT (DILUTED) RESULTS LOWER AND WITHIN THE ASSAY RANGE. SIEMENS HAS REVIEWED THE INSTRUMENT DATA AND SERVICE DOCUMENTATION. THE QUALITY CONTROL (QC) AND CALIBRATION WERE WITHIN CUSTOMER LIMITS AT THE TIME OF THE EVENT. SERVICE WAS DISPATCHED AND THE SALINE MANIFOLD VALUE ALONG WITH THE DILUTION PROBE ARM WAS REPLACED. THE QC AND CALIBRATION WERE OUT OF LIMITS AFTER THAT SERVICE EVENT SO SERVICE RETURNED AND REPLACED THE SAMPLE AND DILUTION MIXERS. THE QC AND CALIBRATION CAME WITHIN PUBLISHED LIMITS AFTER THIS SERVICE EVENT. THE ISSUE WAS RESOLVED WITH ROUTINE MAINTENANCE AND PART REPLACEMENT. REPLACEMENT OF THE PARTS ARE CONSIDERED NORMAL TROUBLESHOOTING OR MAINTENANCE FOR ISSUES OF THIS NATURE; THEREFORE RETURN OF THE PARTS IS NOT WARRANTED. THE CAUSE OF THE ISSUE WAS WITH THE FUNCTION OF THE SAMPLE ASPIRATION, DILUTION AND DELIVERY SYSTEM. EXACT IDENTIFICATION OF THE SPECIFIC PART IS NOT POSSIBLE WITH THE AVAILABLE DATA HOWEVER THE ISSUE WAS RESOLVED WITH ROUTINE MAINTENANCE. THE INTERPRETATION OF RESULTS SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem

THE CUSTOMER OBTAINED AN ABOVE ASSAY RANGE RESULT FOR TACROLIMUS (TACR) ON A PATIENT SAMPLE WHEN PROCESSED ON AN ATELLICA CH 930 INSTRUMENT (S/N (B)(6)). THE PATIENT SAMPLE WAS DILUTED AND REPEATED. THE RESULTS WERE LOWER AND WITHIN THE ASSAY RANGE. THE LOWER DILUTED RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. A NEW SAMPLE FROM THE SAME PATIENT WAS TESTED AND THE RESULT WAS HIGHER AND CONSIDERED TOXIC. THE INITIAL SAMPLE WAS REPEATED AND THE NEAT RESULT WAS SIMILAR TO THE NEW SAMPLE RESULT. THE PATIENT IS AN ORGAN TRANSPLANT RECIPIENT AND WAS GIVEN TACROLIMUS TREATMENT. THE TRANSPLANT TIME FRAME WAS NOT PROVIDED FOR THE PATIENT. THERE ARE NO KNOWN REPORTS ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TACROLIMUS (TACR) RESULTS.