BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FERRITIN

    MDR report key: 20310849 · Received September 26, 2024

    Report

    Report Number
    1823260-2024-02787
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    August 27, 2024
    Report Date
    November 21, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMG
    PMA / PMN Number
    K971833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE CUSTOMER'S COBAS E411 DISK IS (B)(6). THE INVESTIGATION REVIEWED THE 26-AUG-2024 CALIBRATION DATA; THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE QC DATA; THE QC DATA PROVIDED WAS DATED ONE MONTH BEFORE THE DATE OF EVENT AND WAS WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE ALARM TRACE; NO ISSUES WERE NOTED. THE INVESTIGATION REVIEWED THE CUSTOMER'S HANDLING OF PATIENT SAMPLES. THE PATIENT SAMPLE'S CLOTTING TIME WAS ONLY 10 MINUTES; MOST SAMPLE TUBE MANUFACTURERS RECOMMEND A CLOTTING TIME OF 30 MINUTES. THE CUSTOMER USES A FIXED CENTRIFUGE WHICH CAN LEAD TO SLANTED SEDIMENTS RESULTING IN POOR SAMPLE QUALITY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE SERIAL NUMBER OF THE ANALYZER WAS ADDED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FERRITIN (FERRITIN), ELECSYS VITAMIN D TOTAL III, AND ELECSYS VITAMIN B12 IMMUNOASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E411 DISK. THIS MEDWATCH IS FOR THE ELECSYS FERRITIN (FERRITIN) ASSAY. PLEASE REFER TO THE MEDWATCH WITH: A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS VITAMIN D TOTAL III ASSAY. A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS VITAMIN B12 IMMUNOASSAY. THE INITIAL FERRITIN RESULT WAS 1.17 NG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 172.2 NG/ML. THE REPEAT RESULT WAS DEEMED CORRECT BASED ON THE PATIENT'S PREVIOUS RESULTS AND CORRELATION WITH THE PATIENT'S COMPLETE BLOOD COUNT (CBC) BY THE LABORATORY DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098390 ELECSYS FERRITIN RADIOIMMUNOASSAY (TWO-SITE SOLID PHASE), FERRITIN JMG ROCHE DIAGNOSTICS 78845901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown