BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3030944 · Received April 2, 2013

    Report

    Report Number
    1823260-2013-01983
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED WITH THE INFORMATION PROVIDED FOR INVESTIGATION. THE SALT BRIDGES ON THE ISE SYSTEM FOUND BY THE FIELD SERVICE REPRESENTATIVE MOST LIKELY DID NOT HAVE AN IMPACT ON THE SAMPLE RESULTS. BASED ON THE INFORMATION PROVIDED, THE ISSUE WAS MOST PROBABLY CAUSED BY A MIS-SAMPLING OF THE SAMPLE DUE TO POOR SAMPLE QUALITY.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 121 MMOL/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED ON (B)(6) 2013 ON COBAS C501 SERIAL NUMBER (B)(4) AND THE RESULT WAS 131 MMOL/L. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE CUSTOMER DID NOT KNOW IF THE PATIENT WAS ADVERSELY AFFECTED. THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WERE SALT BRIDGES IN THE ISE ASSEMBLY. HE CLEANED THE ISE ASSEMBLY AND VERIFIED THE SYSTEM WITH ISE CHECKS WHICH WERE GOOD. THE CUSTOMER RAN QC WHICH WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133790 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1