BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 7328041 · Received March 9, 2018

    Report

    Report Number
    1823260-2018-00747
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    February 19, 2018
    Report Date
    April 2, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE LOW ELECSYS ESTRADIOL III ASSAY RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 1401.0 PMOL/L AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE CLINICIAN DID NOT THINK THIS RESULT LOOKED CORRECT AS IT DID NOT FIT THE CLINICAL PICTURE. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 8000 E 801 MODULE AND THE RESULT WAS GREATER THAN 11010.0 PMOL/L. THE RESULT AFTER AN AUTOMATIC DILUTION WAS 11948.0 PMOL/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 252576. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. OTHER SAMPLES TESTED FOR ESTRADIOL AROUND THIS TIME WERE REPEATED ON THE OTHER COBAS 8000 ANALYZER AND THE RESULTS WERE COMPARABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169392 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1