BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 4047239 · Received August 29, 2014

    Report

    Report Number
    1823260-2014-06642
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    August 7, 2014
    Report Date
    September 16, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL DATA WERE REQUESTED BUT NOT PROVIDED. THE CALIBRATION AND QUALITY CONTROL WERE WITHIN RANGE AND A GENERAL INSTRUMENT OR CALIBRATION ISSUE SEEMED UNLIKELY AS THE CAUSE. IT WAS NOTED THERE WERE NUMEROUS ALARMS OCCURRING INDICATING THE POSSIBILITY OF POOR SAMPLE QUALITY.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE ESTRADIOL GEN2 RESULT FOR ONE PATIENT ON THEIR E601 ANALYZER. THE PATIENT'S INITIAL ESTRADIOL RESULT WAS 580.5 PG/ML AND IT WAS RELEASED TO THE PHYSICIAN. THE INITIAL RESULT WAS NOT CONSISTENT WITH THE CLINICAL HISTORY OF THE PATIENT. THE PHYSICIAN ASKED THE PATIENT TO RETURN TO THE LABORATORY IN ORDER TO COLLECT A NEW SAMPLE TO CONFIRM THE RESULT. ON (B)(6) 2014, A NEW SAMPLE WAS DRAWN AND THE ESTRADIOL RESULT WAS 5.0 PG/ML. ON (B)(6) 2014, A THIRD SAMPLE WAS DRAWN AND THE ESTRADIOL RESULT WAS 9.2 PG/ML. ON (B)(6) 2014, THE ORIGINAL SAMPLE WAS REPEATED AND THE ESTRADIOL RESULT WAS 12.07 PG/ML. THE INITIAL RESULT WAS CONSIDERED TO BE INCORRECTLY HIGH. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE ESTRADIOL REAGENT LOT NUMBER WAS 173677. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THERE WERE NO BUBBLES OR FOAM ON THE REAGENT SURFACE ON (B)(6) 2014, AND THE PINCH TUBES WERE REPLACED FOLLOWING INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527586 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR