BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 5648034 · Received May 11, 2016

    Report

    Report Number
    1823260-2016-00621
    Event Type
    Malfunction
    Date Received
    May 11, 2016
    Date of Event
    April 28, 2016
    Report Date
    June 6, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. POSSIBLE ROOT CAUSES MAY BE PRE-ANALYTICAL SAMPLE HANDLING, TEMPORARY REAGENT ISSUES SUCH AS BUBBLES, OR A TEMPORARY INSTRUMENT ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY HAD ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR ESTRADIOL ON AN E601 ANALYZER. THE SAMPLE INITIALLY RESULTED AS 11.98 PG/ML. THE SAMPLE WAS REPEATED, RESULTING AS 15.37 PG/ML. THE 15.37 PG/ML VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT. ON (B)(6) 2016, THE PATIENT COMPLAINED ABOUT THE RESULT, SO THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 101.3 PG/ML ACCOMPANIED BY A DATA FLAG ON (B)(6) 2016. THE SAMPLE WAS REPEATED A SECOND TIME ON (B)(6) 2016, RESULTING AS 100.9 PG/ML ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT FROM (B)(6) 2016 WAS CONSIDERED TO BE THE CORRECT RESULT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE ESTRADIOL REAGENT LOT NUMBER WAS 120670. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301813 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1