BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 3670535 · Received March 10, 2014

    Report

    Report Number
    1823260-2014-01668
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    December 17, 2013
    Report Date
    April 1, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LGD
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED ADDITIONAL INFORMATION. THE DISCREPANT RESULTS WERE REPORTED TO THE PHYSICIANS. THE FIRST PATIENT DID NOT HEAR ABOUT THE FALSE POSITIVE RESULT. THE SECOND PATIENT WAS INFORMED ABOUT THE INITIAL POSITIVE RESULTS AND WAS LATER INFORMED SHE WAS NEGATIVE. AS FAR AS THE CUSTOMER KNEW, THE PATIENTS' HEALTH WAS NOT AFFECTED.

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED DUE TO THE LACK OF INFORMATION PROVIDED. ADDITIONAL DETAILS WERE REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE IGG ANTIBODIES TO TOXOPLASMA GONDII (TOXG) RESULTS ON THEIR E602 ANALYZER. THE PATIENTS' SAMPLES WERE ALIQUOTED WITH THE CUSTOMER'S MODULAR PRE ANALYTICS DEVICE INTO SAMPLE CUPS FOR ANALYSIS. THE DOCTOR VISIBLY INSPECTED THE SAMPLES BEFORE REPEAT TESTING AND CONCLUDED THEY DID NOT HAVE ANY SIGNS OF HEMOLYSIS, ICTERUS, OR LIPEMIA. THE FIRST PATIENT'S INITIAL TOXG RESULT WAS 5.39 KU/L WHICH WAS POSITIVE. ON (B)(6) 2013, THE SAMPLE WAS REPEATED AND THE RESULT WAS <1 KU/L WHICH WAS NEGATIVE. ON (B)(6) 2104, THE SECOND PATIENT, A WOMAN, HAD AN INITIAL TOXG RESULT OF 7.87 KU/L WHICH WAS POSITIVE. ON (B)(6) 2014, THE SAMPLE WAS REPEATED AND THE RESULT WAS <1 KU/L WHICH WAS NEGATIVE. INFORMATION ON WHETHER THE DISCREPANT RESULTS WERE REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT NOT PROVIDED. INFORMATION ON WHETHER THE PATIENTS WERE ADVERSELY AFFECTED WAS REQUESTED BUT NOT PROVIDED. THE TOXG REAGENT LOT NUMBER WAS 173848. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143413 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER LGD ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1