BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 SYSTEM

    MDR report key: 2822573 · Received November 7, 2012

    Report

    Report Number
    1823260-2012-05643
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 12, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K003178
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PATIENT WAS NOT ADVERSELY AFFECTED. THE INVESTIGATION COULD NOT DETERMINE A CAUSE DUE TO THE LIMITED INFORMATION PROVIDED. THE CUSTOMER WILL NOT PROVIDE MORE INFORMATION.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6). NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCG+SS) RESULT FOR ONE PATIENT SAMPLE. THE UNIT OF MEASURE WAS NOT PROVIDED. THE INITIAL RESULT WAS 507.7 AND WAS REPORTED OUTSIDE THE LABORATORY. FOUR DAYS LATER, A DOCTOR CALLED THE LABORATORY AND ASKED ABOUT THE RESULT BECAUSE IT WAS NOT CONCORDANT WITH THE PATIENT. THE LABORATORY REPEATED THE SAME SAMPLE AND THE RESULT WAS 137640. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE PATIENT WAS ADVERSELY AFFECTED. THE HCG+SS REAGENT LOT NUMBER WAS 167584.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 SYSTEM IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1