BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 2853291 · Received November 30, 2012

    Report

    Report Number
    1823260-2012-06061
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 18, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCG+SS) RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS <0.1 MIU/ML WITH A DATA FLAG AND WAS REPORTED TO THE PATHOLOGIST. THIS RESULT WAS QUESTIONED AS IT DID NOT CORRELATE WITH A RESULT OF 50 MIU/ML FOR THE PATIENT ON (B)(6)2012. THE SAMPLE WAS REPEATED WITH A RESULT OF 108.5 MIU/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE HCG+SS REAGENT LOT NUMBER WAS 169563 WITH AN EXPIRATION DATE OF 01/30/2014. IT WAS NOTED THE SAMPLE WAS SLIGHTLY HEMOLYZED WITH BIT OF FIBRIN IN THE SERUM. THE CUSTOMER WAS NOT USING THE RECOMMENDED SAMPLE RACK INSERTS. THE FIELD SERVICE ENGINEER FOUND THE BEAD MIXER WAS SLIGHTLY BENT AND REPLACED IT. THE INVESTIGATION COULD NOT DETERMINE SPECIFIC ROOT CAUSE. THE FIBRIN IN THE SAMPLE, TILTED PRIMARY TUBE DUE TO THE LACK OF SAMPLE RACK INSERTS OR THE BENT BEAD MIXER COULD HAVE CAUSED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 CORE CLINICAL CHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 027 YR