BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 3021466 · Received March 26, 2013

    Report

    Report Number
    1823260-2013-01845
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 9, 2013
    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

    THE EVENT OCCURRED IN (B)(6). NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER REPLACED THE CLEANER VALVE AT THE TRANSFER ARM AND OBSERVED THE SYSTEM FOR A WEEK. NO PROBLEMS WERE FOUND AFTER THE REPLACEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED QUESTIONABLE RESULTS WITH THE CREATININE PLUS VER. 2 (CREA) ASSAY. THE CUSTOMER PROVIDED RESULTS FOR ONE PATIENT SAMPLE, WHICH WERE DETERMINED TO BE DISCREPANT. THE INITIAL CREA WAS 1.78 MG/DL. THE RESULT WAS REPORTED THE CLINICIAN WHO DETERMINED IT DID NOT FIT THE PATIENT'S STATUS. HE ASKED THAT THE TEST BE REPEATED. THE TEST WAS REPEATED ONE HOUR LATER WITH A RESULT OF 1.06 MG/DL. THIS RESULT WAS THEN REPORTED. NO TREATMENT WAS PERFORMED DUE TO THE ERRONEOUS RESULT. THERE WERE NO ADVERSE EVENTS. THE CREA REAGENT IN USE WAS LOT NUMBER 67223001 WITH AN EXPIRATION DATE OF 08/30/2013. THE FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND DETERMINED THE CUSTOMER HAD DISABLED ALL EXTRA WASH CYCLES (EWC) ON THE ANALYZER DUE TO BEING OUT OF CLEANER AT THE TIME. DUE TO THE EWCS BEING DISABLED, THE FSE SUSPECTED REAGENT PROBE CARRY OVER. HE ENABLED THE EWCS AND EDUCATED THE CUSTOMER ON THE IMPORTANCE OF THE EWCS. A PRECISION CHECK WAS PERFORMED AND FOUND TO BE ACCEPTABLE. ON (B)(6) 2013 THE CUSTOMER COMPLAINED THAT THE EWCS HAD NOT SOLVED THE PROBLEM. THE FSE THEN REPLACED THE CLEANER SYRINGE. THE CUSTOMER WILL MONITOR THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123401 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1