BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS ISE MODULE

    MDR report key: 11013199 · Received December 15, 2020

    Report

    Report Number
    1823260-2020-03215
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    October 22, 2020
    Report Date
    December 22, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL AND REPEAT ISE POTASSIUM AND CHLORIDE RESULTS WERE REQUESTED, BUT NOT PROVIDED. THE CUSTOMER'S CALIBRATION AND QC RECOVERY WERE REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN GBR.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RECEIVED A DISCREPANT RESULT FOR ONE PATIENT SAMPLE TESTED WITH ISE INDIRECT NA FOR GEN.2 ON A COBAS 8000 ISE MODULE. THE SAMPLE INITIALLY RESULTED WITH AN NA VALUE OF 155 MMOL/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE CLINICIAN. THE RESULT WAS QUESTIONED BECAUSE IT DID NOT FIT THE CLINICAL PICTURE OF THE PATIENT. THE SAMPLE WAS REPEATED, RESULTING WITH AN NA VALUE OF 139 MMOL/L. AN AMENDED REPORT WAS ISSUED. THE NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474956 COBAS 8000 COBAS ISE MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS COBAS 8000 ISE NA

    Patients

    Seq Age Sex Outcome Treatment
    1