BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3061865 · Received April 16, 2013

    Report

    Report Number
    1823260-2013-02325
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZV
    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

    ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE DISCREPANT POTASSIUM RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE FIELD SERVICE REPRESENTATIVE WENT ON SITE. HE PERFORMED A COMPLETE CURATIVE MAINTENANCE ON THE ISE KIT. HE INCREASED THE GEAR PUMP PRESSURE. THERE WERE NO MORE POTASSIUM PROBLEMS.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. DURING THE SERVICE VISIT, MANY ACTIONS WERE PERFORMED AND IT CANNOT BE CLEARLY DETERMINED WHICH ACTION RESOLVED THE ISSUE. THE ANALYZER IS NOW WORKING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE POTASSIUM RESULTS ON THEIR C501 ANALYZER. THE CUSTOMER STATED THERE WERE AT LEAST FIVE PATIENTS INVOLVED IN THIS EVENT. THE CUSTOMER STATED THE SODIUM AND CHLORIDE RESULTS WERE OK. THE UNITS OF MEASURE WERE NOT PROVIDED. THE FIRST PATIENT'S INITIAL POTASSIUM RESULT WAS 10.9. THE FIRST REPEAT RESULT WAS 3.4. THE SECOND REPEAT RESULT WAS 3.5. THE SECOND PATIENT'S INITIAL POTASSIUM RESULT WAS 7. THE FIRST REPEAT RESULT WAS 4.2. THE SECOND REPEAT RESULT WAS 4.2. THE THIRD PATIENT'S INITIAL POTASSIUM RESULT WAS 8.1. THE FIRST REPEAT RESULT WAS 4.7. THE SECOND REPEAT RESULT WAS 4.7. THE FOURTH PATIENT'S INITIAL POTASSIUM RESULT WAS 5.9. THE FIRST REPEAT RESULT WAS 4.7. THE SECOND REPEAT RESULT WAS 4.5. ON (B)(6) 2013, THE FIFTH PATIENT'S INITIAL POTASSIUM RESULT WAS 5.91. THE REPEAT RESULT WAS 4.42. IT WAS UNKNOWN IF ANY RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WERE NO ADVERSE EVENTS. THE POTASSIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162063 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER MZV ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1