BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRT REAGENT

    MDR report key: 2884154 · Received December 21, 2012

    Report

    Report Number
    2432235-2012-00455
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    July 1, 2012
    Report Date
    December 3, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    DBF
    PMA / PMN Number
    K110736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF PATIENT SAMPLES BEING RUN WITH EXPIRED FERRITIN REAGENT IS USER ERROR. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER RAN PATIENT SAMPLES WITH EXPIRED FERRITIN REAGENT. THE QUALITY CONTROLS WERE WITHIN RANGE AND THE PATIENT RESULTS WERE BELIEVABLE TO THE CUSTOMER. IT IS UNKNOWN IF PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO USE OF THE EXPIRED FERRITIN REAGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRT REAGENT FRT REAGENT DBF SIEMENS HEALTHCARE DIAGNOSTICS 219826

    Patients

    Seq Age Sex Outcome Treatment
    1