IMMULITE 2000 FREE T3

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 1219913-2025-00114 ON 12-JUN-2025. ADDITIONAL INFORMATION ON 17-JUN-2025: SIEMENS EVALUATED THIS ISSUE AND PROVIDED THE FOLLOWING CONCLUSION: THE IMMULITE 2000 XPI INSTRUMENT SUBSTRATE PUMP WAS REPLACED, AND A TEST RUN OF THE DILUTION STATION WAS CARRIED OUT. QUALITY CONTROLS (QCS) WERE FOUND WITHIN RANGE AFTERWARDS. HOWEVER, NO FURTHER RESULTS WITH IMMULITE 2000 FREE T3 KIT LOT 125 WERE GENERATED, THE SYSTEM WAS CHECKED AGAIN. THE WASH TUB AND TUBE LIFTER PRESSURE WERE CHECKED AND WERE OK. THE SHAKER BARS WERE CHECKED AND THERE ARE NO SPLASHES ON THE INCUBATOR OR LUMINOMETER LID. THE PHOTOMULTIPLIER TUBE (PMT) SHUTTER WAS CLEAN AND IN POSITION. THE REAGENT AND SAMPLE PIPETTOR POSITIONS ARE OK. THE POSITION OF BOTH REAGENT DUAL RESOLUTION DILUTORS (DRDS) WERE CHECKED AND WERE OK. THE WATER AND SUBSTRATE QUANTITY WAS OK AND THE PRIME WAS EVEN. THE WATER TEST RESULTS WERE ACCEPTABLE. THE REAGENT NEEDLE WAS SUBMERGED BECAUSE THERE WERE DEPOSITS BETWEEN THE TUBES. A TEST WAS RUN WITH QCS AND THE SYSTEM WAS ACCEPTABLE AND RETURNED TO NORMAL OPERATION. THE CUSTOMER DID NOT PERFORM FURTHER TESTING WITH IMMULITE 2000 FREE T3 KIT LOT 125 AFTER THE HARDWARE CHECKS AND REPLACEMENT OF PARTS. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR IMMULITE 2000 FREE T3 KIT LOT 125 IMPRECISION. THE SIEMENS HEALTHINEERS INTERNAL KIT RELEASE DATA WAS ACCEPTABLE FOR IMMULITE 2000 FREE T3 KIT LOT 125. IMMULITE 2000 FREE T3 KIT LOT 125 IS NOW EXPIRED AND FURTHER INVESTIGATION OF THIS KIT LOT IS NOT POSSIBLE. THE CUSTOMER IS OPERATIONAL AT THIS TIME BY SENDING FREE T3 SAMPLES TO ANOTHER LABORATORY. IN SECTION H6, THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

Additional Manufacturer Narrative

AN OUTSIDE THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS REGIONAL SUPPORT CENTER TO REPORT NON-REPRODUCIBLE RESULTS WHEN USING FREE T3 LOT 125 ON AN IMMULITE 2000 XPI INSTRUMENT. QUALITY CONTROL RESULTS ALSO EXHIBITED IMPRECISION ON THE EVENT DATE. THE LIMITATIONS SECTION FOR THE IMMULITE 2000 FREE T3 INSTRUCTIONS FOR USE (IFU) STATES "FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FOR THIS ASSAY SHOULD ALWAYS BE USED IN COMBINATION WITH THE CLINICAL EXAMINATION, PATIENT MEDICAL HISTORY AND OTHER FINDINGS." SIEMENS IS INVESTIGATING.

Description of Event or Problem

THE CUSTOMER REPORTED THE OBSERVATION OF NON-REPRODUCIBLE RESULTS WHEN USING FT3 LOT 125 ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE INITIAL IMMULITE 2000 XPI INSTRUMENT USING FT3 REAGENT LOT 127 AND THE REPEAT RESULT WAS HIGHER THAN THE INITIAL RESULT. IT IS UNKNOWN WHICH RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NON-REPRODUCIBLE FT3 RESULTS.