BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 3267301 · Received August 6, 2013

    Report

    Report Number
    1823260-2013-04740
    Event Type
    Malfunction
    Date Received
    August 6, 2013
    Date of Event
    June 29, 2013
    Report Date
    September 19, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MRG
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER. THE DISCREPANT RESULTS WERE FROM SEPARATE PATIENT SAMPLES. BOTH RESULTS WERE REPORTED OUTSIDE THE LABORATORY. AN ADDITIONAL RESULT OF 6.75 NG/ML ACCOMPANIED BY A DATA FLAG WAS SUPPLIED BY THE CUSTOMER FOR THIS PATIENT. ADDITIONAL INFORMATION HAS BEEN PROVIDED INDICATING THAT THE DATE THE MANUFACTURER WAS MADE AWARE WAS 07/10/2013.

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE CALIBRATION AND QUALITY CONTROL DATA WERE WITHIN RANGE AND A REAGENT ISSUE WAS NOT LIKELY.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN THE (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE 25-HYDROXYVITAMIN D (VITD) RESULT FOR ONE PATIENT ON THEIR E411 ANALYZER. THE PATIENT'S INITIAL VITD RESULT WAS 6.43 NG/ML ACCOMPANIED BY A DATA FLAG AND IT WAS REPORTED TO THE PATIENT. WHEN THE PATIENT'S CONSULTING DOCTOR QUESTIONED THE INITIAL RESULT, A RESAMPLING WAS DONE ON (B)(6) 2013. INFORMATION ON WHETHER THIS WAS FROM THE SAME SAMPLE AS THE INITIAL RESULT WAS REQUESTED, BUT NOT PROVIDED. THE REPEAT RESULT WAS 19.97 NG/ML ACCOMPANIED BY A DATA FLAG. INFORMATION ON WHETHER THE PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED, BUT NOT PROVIDED. THE VITD REAGENT LOT NUMBER WAS 170827 AND THE EXPIRATION DATE WAS 11/29/2013. THE CUSTOMER STATED A RANDOM SAMPLE WAS RUN TWICE TO VERIFY THE ANALYZER PRECISION AND THE RESULTS WERE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368060 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER MRG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 034 YR EURO D VTIMAIN D CAPSULES| VITAMIN D INJECTION (CHOLECALCIFEROL)