BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE® 2000 THYROGLOBULIN

    MDR report key: 15943767 · Received December 8, 2022

    Report

    Report Number
    2432235-2022-00372
    Event Type
    Malfunction
    Date Received
    December 8, 2022
    Date of Event
    April 14, 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

    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. MDRS 2432235-2022-00373, 2432235-2022-00374, 2432235-2022-00375, 2432235-2022-00376, 2432235-2022-00377, AND 2432235-2022-00380 WERE FILED FOR THE SAME EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A LOW BIAS WITH THE IMMULITE® 2000 THYROGLOBULIN (TG) ASSAY ON QUALITY CONTROL AND PATIENT SAMPLES THAT RAN ON THE IMMULITE 2000 XPI INSTRUMENT. THE CUSTOMER INFORMED SIEMENS THAT THE INITIAL RESULTS WERE CORRECT AND REPORTED. THE CUSTOMER PERFORMED REPEAT TESTING ON THE SAME INSTRUMENT FOR TROUBLESHOOTING PURPOSES. THE CUSTOMER DID NOT REPORT ANY TG PATIENT RESULTS WHEN QUALITY CONTROL (QC) INDICATED A LOW BIAS OR WAS OUT OF RANGE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW BIAS OBSERVED WITH THE TG ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136795 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