BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 3050741 · Received April 10, 2013

    Report

    Report Number
    1823260-2013-02195
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 30, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR THREE PATIENT SAMPLES TESTED FOR TROPONIN I STAT (SHORT TURN AROUND TIME) ON (B)(6) 2013. OF THE THREE SAMPLES, ONE SAMPLE FROM (B)(6) 2013 WAS FOUND TO HAVE AN ERRONEOUS RESULT. THE SAMPLE INITIALLY RESULTED AS 0.34 NG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE INITIAL RESULT, SO THE SAMPLE WAS REPEATED USING ISTAT EIA METHODOLOGY. THE REPEAT RESULT WAS 0.00 NG/ML. THE SAMPLE WAS THEN SENT TO ANOTHER SITE WHERE IT WAS REPEATED A SECOND TIME ON AN E602 ANALYZER, RESULTING AS <0.30 NG/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE TROPONIN I STAT REAGENT LOT NUMBER WAS 17026101 WITH AN EXPIRATION DATE OF 01/31/2014. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THERE WAS A MISADJUSTMENT OF THE S/R PROBE. HE PERFORMED AN ADJUSTMENT OF THE S/R PROBE. ALL MECHANICAL AND OPERATIONAL CHECKS PASSED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149188 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER MMI ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1