BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE® 2000 THYROGLOBULIN

    MDR report key: 14526825 · Received May 27, 2022

    Report

    Report Number
    2247117-2022-00019
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    May 6, 2022
    Report Date
    December 8, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    JNL
    PMA / PMN Number
    K982468
    Removal / Correction Number
    2432235-12/06/2022-006-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND NOTED THAT THYROGLOBULIN (TG) QUALITY CONTROLS (QC) ARE RESULTING LOW AND THAT PATIENT DATA SHOWS POOR PRECISION. OTHER ASSAYS ARE PERFORMING AS SPECIFIED. SIEMENS DISPATCHED A CUSTOMER SERVICE ENGINEER (CSE) TO THE CUSTOMER SITE. THE CSE AND CUSTOMER HAVE PERFORMED DECONTAMINATION ON THE IMMULITE 200 XPI INSTRUMENT WITH SODIUM HYDROXIDE (NAOH) AND RE-RUN THE WATERTEST PM. SIEMENS NOTED NO DIFFERENCE IN DATA BEFORE AND AFTER THE DECONTAMINATION, AND THE RESULTS WERE ACCEPTABLE. SIEMENS IS INVESTIGATING THE EVENT.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2247117-2022-00019 ON 27-MAY-2022. SIEMENS FILED THE FIRST SUPPLEMENTAL MDR 2247117-2022-00019_S1 ON 20-JUN-2022. ADDITIONAL INFORMATION (DECEMBER 2022): SIEMENS REVIEWED ADDITIONAL INFORMATION REGARDING THE IMMULITE® 2000 THYROGLOBULIN (TG) REAGENT KIT LOT 431 THAT WAS USED BY THE CUSTOMER AND CONCLUDED NO HARDWARE-RELATED MALFUNCTION WITH THE IMMULITE 2000 XPI INSTRUMENT SERIAL NUMBER (B)(6). SIEMENS HEALTHCARE DIAGNOSTICS FURTHER INVESTIGATED THE ISSUE AND HAS CONFIRMED THE POTENTIAL FOR FUNCTIONAL SENSITIVITY TO NOT MEET INSTRUCTIONS FOR USE CLAIMS WITH THYROGLOBULIN KIT LOTS D431-D436 (US) AND KIT LOTS 431-436 (OUTSIDE THE US). INVESTIGATION HAS ALSO DEMONSTRATED THAT IMMULITE THYROGLOBULIN CONTROL MODULE CONTROL LEVEL ONE MAY RESULT OUTSIDE OF PUBLISHED RANGES. PER GOOD LABORATORY PRACTICE, PATIENT RESULTS ARE NOT REPORTED WHEN CONTROLS RESULT OUT OF RANGE. WHEN CONTROL RESULTS ARE IN RANGE, USERS MAY OBSERVE INCREASED IMPRECISION WITH LOW LEVEL PATIENT SAMPLES. AN URGENT MEDICAL DEVICE CORRECTION (UMDC, LETTER IMC23-04.A.US) WAS SENT TO US CUSTOMERS 12/8/2022, AND AN URGENT FIELD SAFETY NOTICE (UFSN, LETTER IMC23-04.A.OUS) WAS SENT TO OUTSIDE THE US (OUS) CUSTOMERS ON 12/7/2022. THE UMDC AND UFSN EXPLAIN THE POTENTIAL FOR FUNCTIONAL SENSITIVITY NOT MEETING IFU CLAIMS AND INCREASED IMPRECISION WITH PATIENT SAMPLES WITH LOW LEVEL PATIENT SAMPLES. SIEMENS UPDATED CONTACT OFFICE - MANUFACTURING SITE, BASED ON THE ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR ON 27-MAY-2022. ADDITIONAL INFORMATION (07-JUN-2022): SIEMENS RECEIVED ADDITIONAL INFORMATION. THE CUSTOMER INFORMED SIEMENS THAT THEY HAD NO BACK UP INSTRUMENT OR METHOD FOR REPORTING THYROGLOBULIN (TG) RESULTS. THE INITIAL RESULTS WERE CORRECT, AND THE CUSTOMER ONLY RERAN THE SAME SAMPLES FOR TROUBLESHOOTING PURPOSES. THE CUSTOMER DID NOT REPORT ANY TG PATIENT RESULTS WHEN QUALITY CONTROL (QC) INDICATED A LOW BIAS AND WAS OUT OF RANGE. THE CUSTOMER USED A NEW TG REAGENT KIT AND PERFORMED PATIENT SAMPLE TESTING, AND REPORTED RESULTS WITH NO ISSUES. HOWEVER, THE CUSTOMER NOTED THAT QC RESULTS WERE MONITORED AND LATER BECAME OUTSIDE THE ACCEPTABLE RANGES. THE CUSTOMER STATED ONLY ONE ASSAY IS AFFECTED, AND OTHER ASSAYS ARE PERFORMING AS EXPECTED. SIEMENS IS INVESTIGATING THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBTAINED DISCORDANT THYROGLOBULIN (TG) RESULTS ON THE IMMULITE 2000 XPI INSTRUMENT. IT IS UNKNOWN IF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER USED THE SAME SAMPLES AND INSTRUMENT TO PERFORM REPEAT TESTING, AND IT IS UNKNOWN IF REPEAT RESULTS WERE CONSIDERED CORRECT AND OR REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2265836 IMMULITE® 2000 THYROGLOBULIN THYROGLOBULIN IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY JNL SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED N/A 431
    361981 IMMULITE® 2000 THYROGLOBULIN THYROGLOBULIN IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY JNL SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED N/A 431

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown