BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELIX

    MDR report key: 4780577 · Received May 12, 2015

    Report

    Report Number
    4780577
    Event Type
    Malfunction
    Date Received
    May 12, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 11, 2015
    Manufacturer
    EMD MILLIPORE CORPORATION
    Product Code
    FIP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BEGINNING WITH THE START UP IN THE AM FOR MIDNIGHT SHIFT, WE STARTED HAVING QC ISSUES WITH CALCIUMS ON THE CE TO THE POINT WE COULD NOT GET THE QC TO WORK AT ALL. ROCHE HOTLINE WAS CONTACTED AND MULTIPLE PROCEDURES (CLEANS, FLUSHES, RECAL'S, REAGENT DUMPS, ETC.) WERE TRIED. NOTHING FIXED IT. WHEN DAY SHIFT ATTEMPTED THEIR START UP ON THE OTHER ANALYZER (CEE), WE EXPERIENCED THE SAME ISSUE. WHEN WE CALLED SERVICE, WE WERE TOLD THAT THE WATER COMING INTO THE ANALYZERS COULD BE A POTENTIAL CAUSE FOR THE PROBLEM. SERVICE DID COME IN AND DUMPED AND CLEANED THE WATER BATH ON THE CEE, AND CHECKED FOR ANYTHING ON THE INSTRUMENT THAT COULD HAVE CAUSED THE ISSUE. BUT WITH THE PROBLEM OCCURRING ON BOTH ANALYZERS, WE FELT STRONGLY IT WAS THE WATER THAT HAD CAUSED THE PROBLEMS. WE HAD TO DUMP ALL CALCIUM PACKS THAT HAD BEEN LOADED DURING THAT TIME, AS THEY ALL HAD USED WATER FOR DILUTING REAGENTS. BY THE END OF DAY, WE WERE FINALLY ABLE TO GET QC TO WORK AND START REPORTING PTS AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310806 ELIX PURIFIER, WATER (ABSORPTION, DEIONIZATION, MEMBRANE FILTER, FIP EMD MILLIPORE CORPORATION ELIX 100 (CUSTOM) F3MA66536
    310807 ELIX PURIFIER, WATER (ABSORPTION, DEIONIZATION, MEMBRANE FILTER, FIR EMD MILLIPORE CORPORATION ELIX 100 (CUSTOM) F3MA66536
    310808 COBAS 501E TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM JFP ROCHE DIAGNOSTICS GMBH CE (C501) 609429
    310822 COBAS 501E TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM JFP ROCHE DIAGNOSTICS GMBH CEE (C501) 609429

    Patients

    Seq Age Sex Outcome Treatment
    1 * WE HAVE A ROCHE CEE AND CE, AND EVERYTHING WAS IN| LINE AND BOTH WERE IN USE.| USE. THE EVOQUA HAS 2 SYSTEMS SUPPLYING THE ROCHE