BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C701 MODULE

    MDR report key: 5793518 · Received July 14, 2016

    Report

    Report Number
    1823260-2016-00916
    Event Type
    Malfunction
    Date Received
    July 14, 2016
    Date of Event
    June 21, 2016
    Report Date
    July 14, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY HAD BEEN OBSERVING FLAGGED CALIBRATIONS AND CONTROL OUTLIERS FOR SEVERAL WEEKS. THE CUSTOMER ALSO RECEIVED ON A PATIENT QUESTIONABLE RESULT FOR LITHIUM. THE ERRONEOUS RESULT WAS THE INITIAL RESULT OF 2.0 MMOL/L. THIS RESULT WAS REPORTED TO THE PHYSICIAN AND THE PATIENT WAS SENT TO THE HOSPITAL. AT THE HOSPITAL, THE LITHIUM WAS MEASURED AGAIN AND THE RESULT WAS 0.9 MMOL/L. THE INITIAL LABORATORY SAMPLE WAS RUN AGAIN AND IT WAS CONFIRMED TO BE 0.9 MMOL/L. THE PATIENT'S CURRENT CONDITION, MEDICATIONS, AND MEDICAL HISTORY WERE REQUESTED; HOWEVER, NO INFORMATION WAS PROVIDED. THERE WAS NO ADVERSE EVENT REPORTED. THE LITHIUM REAGENT LOT NUMBER IS 133815 WITH AN EXPIRATION DATE OF 11/30/2017. THE FIELD SERVICE ENGINEER WENT TO THE SITE AND FOUND THAT CUVETTE WASHING WAS NOT OPTIMAL. HE OPTIMIZED IT AND THE CUVETTES WERE CHANGED. THE GEAR PUMP PRESSURE WAS TOO LOW, SO HE INCREASED IT. HE DID THE PRECISION MEASUREMENT WITH ANOTHER REAGENT AND STATED IT WAS WITHIN RANGE. THE CUSTOMER HAS NOT EXPERIENCED ANY MORE OUTLIERS. DURING THE INVESTIGATION, IT WAS FOUND THAT THE QC HAD BEEN UNSTABLE AND IT WAS OFTEN OUT OF THE TARGET RANGE. ON THE DATE OF THE EVENT, THE QC WAS OUT OF THE TARGET RANGE SEVERAL TIMES. A SPECIFIC ROOT CAUSE WAS NOT FOUND BUT IT WAS DETERMINED THAT THE MOST PROBABLE CAUSE WAS INCOMPLETE MAINTENANCE. THE ISSUES FOUND BY THE FIELD SERVICE REPRESENTATIVE MAY LEAD TO AN INCOMPLETE WASHING OF THE PROBES AND THEREFORE LEAD TO SAMPLE OR REAGENT CARRY-OVER. THE CUSTOMER STATED THAT THEY HAD NOT NOTICED ANY MORE OUTLIERS SINCE THE FIELD SERVICE ENGINEER HAD MADE THE CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448407 COBAS 8000 C701 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1