BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 3820616 · Received May 20, 2014

    Report

    Report Number
    1823260-2014-03554
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 26, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED BY THE CUSTOMER. ADDITIONAL DATA WERE REQUESTED BUT NOT PROVIDED. THE CALIBRATION AND QUALITY CONTROL RESULTS WERE WITHIN EXPECTATION. IT WAS NOTED THERE WAS A FLAG ON THE QUALITY CONTROL DATA. A REAGENT ISSUES SEEMED UNLIKELY, BUT COULD NOT BE EXCLUDED. IT WAS NOTED THE CUSTOMER WAS NOT FOLLOWING TUBE MANUFACTURER'S CENTRIFUGATION RECOMMENDATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE TESTOSTERONE G2 RESULT FOR ONE PATIENT ON THEIR E602 ANALYZER. ALL THE OTHER HORMONE TESTS WERE ALSO REPEATED AND THE RESULTS WERE THE SAME AS THE INITIAL RESULTS. THE PATIENT'S PRIMARY SAMPLE WAS LOADED DIRECTLY ONTO THE ANALYZER AND THE INITIAL TESTOSTERONE RESULT WAS 22.46 NMOL/L. THE INITIAL RESULT HAD A REPEAT REQUESTED, BUT IT WAS NOT PERFORMED. ON(B)(6) 2014, THE SAMPLE WAS REPEATED WITH A RESULT OF 0.321 NMOL/L. THE SAMPLE WAS TESTED A THIRD TIME WITH A RESULT OF 0.364 NMOL/L. THE CUSTOMER STATED THE INITIAL RESULT MIGHT HAVE BEEN REPORTED OUTSIDE THE LABORATORY, BUT AS THE INITIAL RESULT WAS UNBELIEVABLE, THE CLINICIAN DID NOT ACT ON THE RESULT. THE PATIENT WAS NOT HARMED IN ANY WAY. THERE WERE NO ADVERSE EVENTS. THE TESTOSTERONE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300052 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 018 YR