BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FERRITIN

    MDR report key: 19792657 · Received July 22, 2024

    Report

    Report Number
    1823260-2024-02104
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    June 21, 2024
    Report Date
    September 4, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMG
    UDI-DI
    04015630939688
    PMA / PMN Number
    K971833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS E801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE CALIBRATION WAS LAST PERFORMED ON (B)(6) 2024 AND IT WAS ACCEPTABLE. QC WAS WITHIN RANGE ON THE DAY OF THE EVENT. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THERE IS NO INDICATION OF A REAGENT ISSUE SINCE THE QC WAS WITHIN THE TARGET RANGES. NO PROBLEM WAS DETECTED SINCE THE CUSTOMER CONSIDERED THE HIGHER RESULTS (TESTED WITH ELECSYS FERR ASSAY) CORRECT. ASSAYS FROM DIFFERENT MANUFACTURERS CAN GENERATE DIFFERENT RESULTS. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS, AND THE STANDARDIZATION METHODOLOGY USED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' SERUM/PLASMA SAMPLES TESTED WITH ELECSYS FERRITIN (FERR) ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO A CHEMILUMINESCENCE METHODOLOGY AT A DIFFERENT FACILITY. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 737 NG/ML. 1ST REPEAT RESULT: 709 NG/ML. 2ND REPEAT RESULT: 422.2 NG/ML (TESTED WITH CHEMILUMINESCENCE). SAMPLE 2 (PATIENT 2): INITIAL RESULT: 375 NG/ML. 1ST REPEAT RESULT: 359 NG/ML. 2ND REPEAT RESULT: 232.0 NG/ML (TESTED WITH CHEMILUMINESCENCE). SAMPLE 3 (PATIENT 3): INITIAL RESULT: 174 NG/ML. REPEAT RESULT: 92.8 NG/ML (TESTED WITH CHEMILUMINESCENCE). THE CUSTOMER QUESTIONED THE INITIAL RESULTS AND REPEATED THE SAMPLES. THE INITIAL RESULTS WERE CONSIDERED CORRECT AND REPORTED OUTSIDE THE LABORATORY. ONLY 1 PATIENT QUESTIONED THEIR RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119328 ELECSYS FERRITIN FERRITIN IMMUNOLOGICAL TEST SYSTEM JMG ROCHE DIAGNOSTICS 76245601 04015630939688

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male