BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3994319 · Received August 8, 2014

    Report

    Report Number
    1823260-2014-06038
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 13, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. IT IS VERY LIKELY THAT THE USE OF A SECONDARY TUBE IN COMBINATION WITH LOW SAMPLE VOLUME CAUSED THE ISSUE.

    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 AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE (PROBNP). THE SAMPLE INITIALLY RESULTED AS 18 PG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED AND RESULTED AS 7237 PG/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE CUSTOMER STATED THEY HAD NO OTHER ISSUES WITH DISCREPANT RESULTS THAT DAY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE PROBNP REAGENT LOT NUMBER WAS 17515003 WITH AN EXPIRATION DATE OF (B)(6) 2015. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE CHECKED ALL ALIGNMENTS AND RAN PERFORMANCE TESTING IN THE UNIT. THE PERFORMANCE TESTING WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467784 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR