BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 2494499 · Received March 16, 2012

    Report

    Report Number
    1823260-2012-01485
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    March 14, 2012
    Report Date
    March 16, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZV
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD ERRONEOUS RESULTS FOR NINE PATIENT SAMPLES TESTED FOR ION SELECTIVE ELECTRODE (ISE) POTASSIUM. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED ON A DIFFERENT COBAS 6000 C501 MODULE. THE REPEAT RESULTS WERE CONSIDERED TO BE CORRECT AND AMENDED REPORTS WERE ISSUED. SAMPLE ONE INITIALLY RESULTED AS 6.1 MMOL/L AND REPEATED AS 4.2 MMOL/L. SAMPLE TWO INITIALLY RESULTED AS 6.0 MMOL/L AND REPEATED AS 3.6 MMOL/L. SAMPLE THREE INITIALLY RESULTED AS 6.1 MMOL/L AND REPEATED AS 3.8 MMOL/L. SAMPLE FOUR INITIALLY RESULTED AS 5.2 MMOL/L AND REPEATED AS 3.2 MMOL/L. SAMPLE FIVE INITIALLY RESULTED AS 5.0 MMOL/L AND REPEATED AS 3.7 MMOL/L. SAMPLE SIX INITIALLY RESULTED AS 5.0 MMOL/L AND REPEATED AS 3.7 MMOL/L. SAMPLE SEVEN INITIALLY RESULTED AS 4.8 MMOL/L AND REPEATED AS 3.8 MMOL/L. SAMPLE EIGHT INITIALLY RESULTED AS 5.8 MMOL/L AND REPEATED AS 3.7 MMOL/L. SAMPLE NINE INITIALLY RESULTED AS 5.8 MMOL/L AND REPEATED AS 3.7 MMOL/L. THE PATIENTS WERE NOT ADVERSELY AFFECTED BY THE EVENT. THE POTASSIUM ELECTRODE LOT NUMBER WAS V89 WITH AN EXPIRATION DATE OF 12/31/2012. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THE ISE SIPPER NOZZLE WAS DEFECTIVE. HE REPLACED THE SIPPER NOZZLE AND TESTED OPERATION. HE PERFORMED CALIBRATION, QUALITY CONTROL, AND A PRECISION CHECK; ALL WERE WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER MZV ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1