IMMULITE 2000 XPI UNCONJUGATED ESTRIOL (UE3)

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT DISCORDANT LOW PATIENT SAMPLE RESULTS WHEN USING IMMULITE 2000 UNCONJUGATED ESTRIOL KIT LOT 494, IN COMPARISON TO THE VALUES EXPECTED BY THE CUSTOMER. THE CUSTOMER HAD NEVER OBSERVED RESULTS <0.07 NG/ML (BELOW THE REPORTABLE RANGE FOR IMMULITE 2000 UNCONJUGATED ESTRIOL) AND QUESTIONED THE UNEXPECTED RESULTS. THE TRUE VALUE IS UNKNOWN. THIS MDR HAS BEEN FILED CONSERVATIVELY DUE TO SIMILAR INCIDENTS OBSERVED BY THIS CUSTOMER WHICH WERE REPORTABLE PER 21 CFR 803. THE LIMITATIONS SECTION OF THE IMMULITE 2000 UNCONJUGATED ESTRIOL INSTRUCTIONS FOR USE STATES THE FOLLOWING: "FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD ALWAYS BE USED IN COMBINATION WITH THE CLINICAL EXAMINATION, PATIENT MEDICAL HISTORY, AND OTHER FINDINGS." SIEMENS IS INVESTIGATING. MDR 2432235-2023-00051, MDR 2432235-2023-00052, AND MDR 2432235-2023-00053 WERE ALSO FILED FOR A SIMILAR INCIDENT WITH IMMULITE 2000 UE3 KIT LOT 496 ON (B)(6) 2023. MDR 2432235-2023-00054, MDR 2432235-2023-00055, AND MDR 2432235-2023-00056 WERE ALSO FILED FOR A SIMILAR INCIDENT WITH IMMULITE 2000 UE3 KIT LOT 494 ON FEBRUARY 10, 2023.

Description of Event or Problem

THE CUSTOMER OBSERVED DISCORDANT LOW PATIENT SAMPLE RESULTS WHEN USING IMMULITE 2000 UNCONJUGATED ESTRIOL (UE3) KIT LOT 494, IN COMPARISON TO THE VALUES EXPECTED BY THE CUSTOMER. THE INITIAL RESULTS WITH KIT LOT 494 WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2432235-2023-00057 ON 10-FEBRURARY-2023. ADDITIONAL INFORMATION ON 22-MARCH-2023: SIEMENS HAS COMPLETED THE INVESTIGATION INTO LOW IMMULITE 2000 UNCONJUGATED ESTRIOL (UE3) RESULTS OBTAINED FOR FOUR SAMPLES. SIEMENS HAS BEEN ASKED TO PROVIDE A TECHNICAL EVALUATION OF THIS CASE WHERE TWO SAMPLES REPORTED <0.07 NG/ML ON KIT LOT 494 BUT 0.105 NG/ML AND 0.226 NG/ML ON KIT LOT 495, AND TWO SAMPLES REPORTED <0.07 NG/ML WHICH WERE CONSIDERED LOW BY THE CUSTOMER THOUGH NO REPEAT RESULTS >0.07 NG/ML WERE OBTAINED FOR THESE TWO SAMPLES. FOR UE3 THE MEDIAN VALUES FOR WEEKS 26 AND UP ARE ANYWHERE FROM 4 TO 12 NG/ML. THE VALUES OF <0.07, 0.105, AND 0.226 NG/ML ARE NEAR OR AT THE LOWER PART OF THE REPORTING RANGE. SIEMENS REQUESTED, THREE TIMES, WHAT THE MULTIPLE OF THE MEDIAN (MOM) VALUES WERE HOWEVER CUSTOMER DID NOT RESPOND WITH ANY FOLLOW-UP INFORMATION. THE DIFFERENCE BETWEEN 0.07, 0.105, AND 0.226 NG/ML COULD BE DUE TO SHIPPING THE SAMPLE. SIEMENS REQUESTED SAMPLES FOR TESTING HOWEVER NO RESPONSE WAS RECEIVED. REVIEWED IN-HOUSE DATA AND A SET OF UE3 PATIENT PANELS ARE RUN AT EVERY KIT RELEASE. KIT LOTS 494, 495, 496 WERE REVIEWED AND ALL SAMPLES MET THE EXPECTED VALUES. SIEMENS IS UNABLE TO DETERMINE A POTENTIAL ROOT CAUSE AS NO FURTHER INFORMATION WAS PROVIDED. SIEMENS HAS NO DATA SUGGESTING MOM VALUES WOULD BE DIFFERENT. NO FURTHER DISCREPANTS REPORTED. THE IMMULITE 2000 UNCONJUGATED ESTRIOL (UE3) KIT LOT 494 IS PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. NOTE: IN SECTION H6, THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES WERE UPDATED.