BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 3772046 · Received April 25, 2014

    Report

    Report Number
    1823260-2014-03056
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 25, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 (ISE) SODIUM RESULTS ON THEIR INTEGRA 400 ANALYZER. THE CUSTOMER PROVIDED DATA FOR THREE PATIENTS WITH DISCREPANT RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER STATED THE PATIENT SAMPLES WERE LATER REPEATED ON A C501 ANALYZER. THE FIRST PATIENT'S INITIAL SODIUM RESULT WAS 119 MMOL/L ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 138 MMOL/L. THE SECOND PATIENT'S INITIAL SODIUM RESULT WAS 119 MMOL/L ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 139 MMOL/L. THE THIRD PATIENT'S INITIAL SODIUM RESULT WAS 116 MMOL/L ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 138 MMOL/L. THE CUSTOMER STATED THAT THEY RECEIVED CALIBRATION AND QUALITY CONTROL ALARMS ON THE ANALYZER ON (B)(4) 2014. AFTER THEY RE-CALIBRATED, THE QUALITY CONTROL WAS IN RANGE BUT PATIENT RESULTS WERE STILL LOW. THE PATIENTS WERE NOT ADVERSELY AFFECTED BY THIS EVENT. THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE FIELD SERVICE REPRESENTATIVE MANUALLY CLEANED THE ISE TOWER. HE CHECKED THE AIR MIX AND AIR DRY PATHS. HE FOUND THEY WERE BOTH LOWER THAN THE GUIDELINES. HE ADJUSTED THEM BOTH. THE INSTRUMENT WAS WORKING TO SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250954 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1