BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 8239164 · Received January 11, 2019

    Report

    Report Number
    1823260-2019-00139
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    December 27, 2018
    Report Date
    February 15, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER RETURNED AND EXCHANGED SV27 AND 28 (BOTH IN ISE SIPPER LINE). THE INVESTIGATION DETERMINED THAT THE ISSUE FOUND BY THE FIELD SERVICE ENGINEER WAS THE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF MULTIPLE OCCURRENCES OF QUESTIONABLE ISE INDIRECT NA, K FOR GEN.2 RESULTS FROM A COBAS 6000 C (501) MODULE. THE SODIUM RESULTS FOR 7 PATIENTS WERE A REPORTABLE MALFUNCTION AND THE POTASSIUM RESULT FOR 1 PATIENT WAS A REPORTABLE MALFUNCTION. FOR PATIENT 1 THE INITIAL SODIUM RESULT WAS 151 MMOL/L WITH A REPEAT RESULT OF 141 MMOL/L. FOR PATIENT 2 THE INITIAL SODIUM RESULT WAS 154 MMOL/L WITH A REPEAT RESULT OF 143 MMOL/L. FOR PATIENT 3 THE INITIAL SODIUM RESULT WAS 158 MMOL/L WITH A REPEAT RESULT OF 142 MMOL/L. FOR PATIENT 4 THE INITIAL SODIUM RESULT WAS 160 MMOL/L WITH A REPEAT RESULT OF 146 MMOL/L. FOR PATIENT 5 THE INITIAL SODIUM RESULT WAS 175 MMOL/L WITH A REPEAT RESULT OF 182 MMOL/L. ON (B)(6) 2019 FOR PATIENT 6, THE INITIAL SODIUM RESULT WAS 180 MMOL/L WITH A REPEAT RESULT OF 142 MMOL/L. THE INITIAL POTASSIUM RESULT WAS 7.05 MMOL/L WITH A REPEAT RESULT OF 5.6 MMOL/L ON (B)(6) 2019 FOR PATIENT 7, THE INITIAL SODIUM RESULT WAS 168 MMOL/L WITH A REPEAT RESULT OF 152 MMOL/L. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SODIUM AND POTASSIUM ELECTRODE LOT INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE CUSTOMER STATED THAT THEY HAVE BEEN HAVING SPORADIC ISE ALARMS. A FIELD ENGINEERING SPECIALIST FOUND SOME DIRT ON THE RINSE STATION. HE FOUND AND REMOVED SOME CRYSTALLIZATION ON THE WASHING UNIT. HE RINSED THE WASHING UNIT, REPLACED A VALVE UNIT, REPLACED THE RINSE STATION TUBING, ADJUSTED THE VOLUME OF THE RINSE STATION, EXCHANGED THE ISE ACRYLIC BLOCK, AND EXCHANGED AND ADJUSTED THE TIPS OF THE RINSE UNIT. THE INVESTIGATION IS CURRENTLY ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33435 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1