BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FERRITIN

    MDR report key: 23594548 · Received November 19, 2025

    Report

    Report Number
    1823260-2025-04708
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    July 22, 2025
    Report Date
    March 13, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMG
    UDI-DI
    04015630939688
    PMA / PMN Number
    K971833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT-RELATED INFORMATION AND RESULTS WERE PROVIDED. MEDWATCH FIELD B7 WAS UPDATED. NEW EXTRACTIONS FROM THE SAME PATIENTS WERE USED FOR THE LATEST RESULTS FROM (B)(6) 2025: PATIENT 1: 282 NG/ML USING THE E801. PATIENT 2: 913 NG/ML USING THE E801 (ACCOMPANIED WITH A DATA FLAG). A NEW SAMPLE WAS TESTED AT AN EXTERNAL LAB AND THE RESULT WAS 742 NG/ML. PATIENT 3: 238 NG/ML USING THE E801. A NEW SAMPLE WAS TESTED AT AN EXTERNAL LAB AND THE RESULT WAS 149 NG/ML THE ABOVE 3 SAMPLES GENERATED ON THE E801 WERE SENT FOR INVESTIGATION. THE CUSTOMER VALUES COULD BE REPRODUCED ON THE COBAS E 801 AND WERE ALSO CONFIRMED WITH A SECOND FERRITIN METHOD ON COBAS C MODULE. THE CUSTOMER'S QC DATA ARE WITHIN RANGE AND COMPARABLE TO PEER DATA. ASSAYS FROM DIFFERENT VENDORS CAN GENERATE DIFFERENT VALUES. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS/METHODS, AND THE STANDARDIZATION METHODOLOGY USED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE ANALYZER IS: (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FERRITIN RESULTS FOR THREE PATIENT SAMPLES TESTED ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1 - SEPARATE SAMPLES WERE TESTED: ON (B)(6) 2025, THE RESULT WAS 164 NG/ML USING THE SIEMENS ASSAY. ON (B)(6) 2025, THE RESULT WAS 223 NG/ML USING THE SIEMENS ASSAY. ON (B)(6) 2025, THE RESULT WAS 587 NG/ML USING THE ELECSYS ASSAY. PATIENT 2 - TWO SAMPLES FROM THE SAME PATIENT WERE TESTED: ON (B)(6) -2025, THE RESULT WAS 602 NG/ML USING THE ELECSYS ASSAY. ON THE SAME DAY, THE SAME SAMPLE WAS REPEATED AT AN EXTERNAL LABORATORY AND THE RESULT WAS 341 NG/ML USING A CHEMILUMINESCENCE IMMUNOASSAY. ON (B)(6) 2025, THE RESULT WAS 373 NG/ML USING THE ELECSYS ASSAY. ON THE SAME DAY, THE SAME SAMPLE WAS REPEATED AT AN EXTERNAL LABORATORY AND THE RESULT WAS 212 NG/ML USING A CHEMILUMINESCENCE IMMUNOASSAY. PATIENT 3 - SEPARATE SAMPLES WERE TESTED: ON (B)(6) 2025, THE RESULT WAS 392 NG/ML USING THE SIEMENS ASSAY. ON (B)(6) 2025, THE RESULT WAS 508 NG/ML USING THE ELECSYS ASSAY. ON (B)(6) 2025, THE RESULT WAS 616 NG/ML USING THE ELECSYS ASSAY. ON (B)(6) 2025, THE RESULT WAS 38.4 NG/ML, PERFORMED BY AN EXTERNAL LABORATORY. ON (B)(6) 2025, THE RESULT WAS 590 NG/ML USING THE ELECSYS ASSAY. ON (B)(6) 2025, THE RESULT WAS 369.4 NG/ML, PERFORMED BY AN EXTERNAL LABORATORY 1. ON (B)(6) 2025, THE RESULT WAS 390 NG/ML, PERFORMED BY AN EXTERNAL LABORATORY 2. IT WAS REPORTED THAT THE RESULTS OF PATIENTS 1 AND 3 DID NOT MATCH THE CLINICAL STATUS OF THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2362310 ELECSYS FERRITIN FERRITIN IMMUNOLOGICAL TEST SYSTEM JMG ROCHE DIAGNOSTICS 83924901 04015630939688

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown