BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2934314 · Received January 30, 2013

    Report

    Report Number
    1823260-2013-00524
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR SEVEN PATIENT SAMPLES FOR MULTIPLE ASSAYS. THE CUSTOMER SPOKE TO THE FIELD SERVICE REPRESENTATIVE AND WAS INSTRUCTED TO REPLACE THE SAMPLE PROBE. AFTER THE PROBE REPLACEMENT, THE CUSTOMER STATED THE ISSUE WAS RESOLVED. THE SAMPLES WERE THEN REPEATED ON THE SAME ANALYZER. OF THE DATA PROVIDED, ONLY THE CREATININE PLUS VERSION 2 RESULT FOR ONE PATIENT SAMPLE WAS DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE INITIAL RESULT WAS 15 MG/DL. THE REPEAT RESULT WAS 0.6 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CREATININE REAGENT LOT NUMBER WAS 66900201 WITH AN EXPIRATION DATE OF 06/30/2013. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE SAMPLE PROBE. AFTER REPLACEMENT OF THE PROBE, HE INSTRUCTED THE CUSTOMER TO PERFORM PRECISION ON SEVERAL ASSAYS. THE CUSTOMER DID THIS, AND COMMUNICATED THAT THE PRECISION WAS GOOD AND THEY WERE NO LONGER HAVING ANY QUESTIONABLE RESULTS. UPON FOLLOW UP WITH THE CUSTOMER, THE FIELD SERVICE REPRESENTATIVE PERFORMED PRECISION ON ANALYZER AND STATED THE CUSTOMER HAS NOT HAD ANY OTHER ISSUES WITH SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41371 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1