BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 ESTRADIOL

    MDR report key: 20868435 · Received December 6, 2024

    Report

    Report Number
    1219913-2024-00494
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 6, 2024
    Report Date
    March 18, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    CHP
    UDI-DI
    00630414966106
    PMA / PMN Number
    K932926
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2024-00494 ON 06-DEC-2024. ADDITIONAL INFORMATION 17-MAR-2025: SIEMENS EVALUATED THE ISSUE AND CAME TO THE FOLLOWING CONCLUSION: SIEMENS HAS REVIEWED THE SPY FILES, MAIN DATABASE AND ERROR LOG FILE PROVIDED. THERE WERE NO ERRORS SEEN THAT WOULD CAUSE DISCORDANT RESULTS AT THE TIME THE SAMPLE WAS PROCESSED. BASED ON THE FILE REVIEW FOR THE SAMPLE THERE IS NO INDICATION THAT THE SAMPLE AND REAGENT PROBES CAUSED THE DISCORDANT RESULTS. THERE WAS NO INDICATION OF LEVEL SENSE ISSUES OR BUBBLES FOUND. THE CUSTOMER IS OPERATIONAL AS THIS IS SPECIFIC TO THE SAMPLE AND THE CAUSE OF THE DIFFERENT RESULTS IS CONSISTENT WITH A SAMPLE INTEGRITY ISSUE. THE CUSTOMER IS ABLE TO RUN OTHER SAMPLES WITH THE SAME ASSAY WITHOUT ANY ISSUES. A PRODUCT ISSUE WAS NOT IDENTIFIED. THE IMMULITE 2000 XPI ESTRADIOL KIT LOT 615 IS PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES WERE UPDATED.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT A DISCORDANT ESTRADIOL RESULT OBTAINED ON A VETERINARY PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. QUALITY CONTROLS (QCS) RECOVERED WITHIN RANGES AT THE TIME OF THE EVENT. PER THE LIMITATIONS SECTION IN THE IMMULITE 2000 ESTRADIOL INSTRUCTIONS FOR USE (IFU): "FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS. IF THE ESTRADIOL RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT." SIEMENS IS INVESTIGATING. THIS OUS PRODUCT (CATALOG NUMBER 10381178, AS LISTED IN D4) IS ASSOCIATED WITH SIMILAR PRODUCT IN THE UNITED STATES: CATALOG NUMBER 10702833 / PREMARKET APPROVAL (PMA)# K932926.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE OBSERVATION OF A DISCORDANT ESTRADIOL RESULT OBTAINED ON A VETERINARY PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND AN ALTERNATE INSTRUMENT AT ANOTHER LAB, AND THE RESULT OBTAINED AT THE OTHER LAB WAS LOWER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ESTRADIOL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120028 IMMULITE 2000 ESTRADIOL RADIOIMMUNOASSAY, ESTRADIOL CHP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED N/A 615 00630414966106

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown