BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 4713546 · Received April 21, 2015

    Report

    Report Number
    1823260-2015-03175
    Event Type
    Malfunction
    Date Received
    April 21, 2015
    Date of Event
    March 14, 2015
    Report Date
    June 11, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. AN INSTRUMENT ISSUE WAS UNLIKELY AS ALL INSTRUMENT DATA WAS CHECKED AND WAS WITHIN SPECIFICATION. THE QC AND CALIBRATION DID NOT INDICATE ANY ISSUES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE IGG ANTIBODY TO TOXOPLASMA GONDII (TOXO IGG) RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 238.8 IU/ML (POSITIVE) AND WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS REDRAWN AND TESTED ON (B)(6) 2015 AND THE RESULT WAS 0.130 IU/ML WITH A DATA FLAG TWICE (NEGATIVE). A SAMPLE FROM THE SAME VENIPUNCTURE AS THE SAMPLE THAT PRODUCED THE INITIAL RESULT WAS TESTED AND THE RESULT WAS 0.130 IU/ML WITH A DATA FLAG (NEGATIVE). THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 180929. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264723 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1