BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 6232268 · Received January 9, 2017

    Report

    Report Number
    1823260-2017-00034
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Date of Event
    December 20, 2016
    Report Date
    February 8, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE FIELD SERVICE REPRESENTATIVE REPORTED THAT THE CUSTOMER HAD ISSUES WITH THEIR PREANALYTICAL PROCEDURES. UPON FOLLOW UP, THE CUSTOMER CONFIRMED THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS HCG + BETA TEST SYSTEM RESULTS FOR FOUR PATIENT SAMPLES. PATIENT 1 INITIAL RESULT WAS 59.72 MUI/ML WITH A DATA FLAG. THE REPEAT RESULT ON A COBAS 6000 E 601 MODULE ANALYZER WAS <0.100 MUI/ML WITH A DATA FLAG. THIS RESULT WAS REPORTED TO THE PATIENT AND WAS CONSIDERED TO BE CORRECT. THE SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER AND THE RESULT WAS <0.100 MUI/ML. PATIENT 2 INITIAL RESULT ON (B)(6) 2016 WAS 14.85 MUI/ML WITH A DATA FLAG. THE REPEAT RESULT ON THE SAME ANALYZER WAS <0.100 MUI/ML WITH A DATA FLAG. THIS RESULT WAS REPORTED TO THE PATIENT AND WAS CONSIDERED TO BE CORRECT. THIS PATIENT WAS FEMALE. PATIENT 3 INITIAL RESULT ON (B)(6) 2016 WAS 4.23 MUI/ML WITH A DATA FLAG. THE REPEAT RESULT ON THE SAME ANALYZER WAS <0.100 MUI/ML WITH A DATA FLAG. THIS RESULT WAS REPORTED TO THE PATIENT AND WAS CONSIDERED TO BE CORRECT. THIS PATIENT WAS FEMALE. PATIENT 4 INITIAL RESULT ON (B)(6) 2016 WAS 2.73 MUI/ML WITH A DATA FLAG. THE REPEAT RESULT ON THE SAME ANALYZER WAS <0.100 MUI/ML WITH A DATA FLAG. THIS RESULT WAS REPORTED TO THE PATIENT AND WAS CONSIDERED TO BE CORRECT. THIS PATIENT WAS FEMALE. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 15654200 WITH AN EXPIRATION DATE OF 09/30/2017. THE FIELD SERVICE REPRESENTATIVE PERFORMED AN ALIGNMENT OF THE BLACK TUBES, DECONTAMINATED, AND CHECKED THE PROBE LIQUID LEVEL DETECTION. DURING THE CHECK, HE FOUND A FAILURE AT CIRCUIT BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18369 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 RACK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR