BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 SYSTEM

    MDR report key: 3053447 · Received April 11, 2013

    Report

    Report Number
    1823260-2013-02232
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 22, 2013
    Report Date
    September 11, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MRG
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT.

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED. THE CALIBRATION AND QUALITY CONTROL DATA WERE OK. THE ASSAY PERFORMANCE CHECK DATA INDICATE THE ANALYZER WAS PERFORMING WITHIN SPECIFICATION. THERE WERE NO OBVIOUS REAGENT OR ANALYZER ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE 25-HYDROXYVITAMIN D (VITD) RESULTS ON THEIR E411 ANALYZER. THE CUSTOMER PROVIDED DATA FOR EIGHT PATIENTS, FOUR OF WHICH HAD DISCREPANT RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT SAMPLES WERE ALSO TESTED USING AN AGILANT 1260 HPLC SYSTEM THE NEXT DAY. THE FIRST PATIENT'S VITD RESULT FROM THE E411 WAS 22.21 NG/ML. THE RESULT FROM HLPC WAS 34.14 UG/L. THE SECOND PATIENT, A FEMALE BORN (B)(6), HAD AN INITIAL VITD RESULT OF 10.22 NG/ML FROM THE E411. THE RESULT FROM HLPC WAS 36.13 UG/L. THE THIRD PATIENT, A FEMALE BORN (B)(6), HAD AN INITIAL VITD RESULT OF 28.87 NG/ML FROM THE E411. THE RESULT FROM HLPC WAS 56.45 UG/L. THE FOURTH PATIENT'S INITIAL VITD RESULT FROM THE E411 WAS 4.77 NG/ML. THE RESULT FROM HLPC WAS 12.49. THERE WERE NO REPORTS OF ANY ADVERSE EVENTS. THE VITD REAGENT LOT NUMBER WAS 170827 AND THE EXPIRATION DATE WAS 11/29/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156051 COBAS E411 SYSTEM IMMUNOCHEMISTRY ANALYZER MRG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR