BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1667942 · Received April 27, 2010

    Report

    Report Number
    1823260-2010-02512
    Event Type
    Malfunction
    Date Received
    April 27, 2010
    Date of Event
    April 13, 2010
    Report Date
    May 14, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    CORRECTION: SODIUM REPEAT RESULT FOR SAMPLE 1 WAS NOT REPORTED IN INITIAL MEDWATCH. REPEAT SODIUM RESULT FOR SAMPLE 1 GAVE 139 MMOL/L. THE 6 REPEAT SODIUM RESULT REPORTED IN INITIAL MEDWATCH ARE FOR SAMPLES 2 THROUGH 7.

    Description of Event or Problem · 1

    USER EXPERIENCED OUT OF RANGE CALIBRATION ERRORS AND LOW SODIUM RESULTS FOR 7 PATIENT SAMPLES. USER COULD NOT PROVIDE THE ACTUAL RESULTS FOR THESE PATIENT SAMPLES, HOWEVER DID STATE THE ORIGINAL RESULTS WERE IN THE 120S MMOL/L. THE 7 PATIENT SAMPLES WERE REPEATED GIVING 141, 142, 138, 136, 140 AND 143 MMOL/L. THE ORIGINAL RESULTS WERE NOT REPORTED OUT. SODIUM ELECTRODE LOT NUMBER - 21595202. THE CUSTOMER ACTIVATED THE ELECTRODES AS PART OF CORRECTIVE MAINTENANCE WHICH RESOLVED THE ISSUE. THE CUSTOMER RAN CALIBRATION AND CONTROLS WHICH WERE SUCCESSFUL.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A PT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. THE CLINICIANS REMOVED THE PADS AND ATTACHED PADDLES AND NO ECG SIGNAL WAS OBTAINED. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1