BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA LABCELL

    MDR report key: 1894883 · Received November 5, 2010

    Report

    Report Number
    2432235-2010-00163
    Event Type
    Other
    Date Received
    November 5, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K083339
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) RETRIEVED THE ELECTRONIC DATA REMOTELY FROM THE CUSTOMER'S LABCELL SYSTEM. BASED ON THE INSTRUMENT DATA THERE WERE NO OBVIOUS ERRORS THAT EXPLAINED THE DELAY IN PROCESSING THE SAMPLE. A FSE WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE FOUND THAT THERE WAS A HEAVY BUILDUP OF DEBRIS BETWEEN THE SIDE TRACK OF THE LABCELL AND THE MAIN TRACK AROUND THE CENTAUR 1 AND CENTAUR 2 INSTRUMENTS. THE FSE CLEANED THE TRACK AND REPLACED THE INTERFACE GATE AT CENTAUR 2. BASED ON THE INFO PROVIDED AND ANALYSIS OF THE INSTRUMENT THE FSE WAS ABLE TO CONCLUDE THAT THE SAMPLE WAS DELAYED DUE TO THE BUILDUP OF DEBRIS ON THE TRACK. THE FSE REMINDED THE CUSTOMER TO FOLLOW THE DAILY MAINTENANCE INSTRUCTIONS OUTLINED IN THE ADVIA AUTOMATION SOLUTIONS OPERATOR'S GUIDE TO ENSURE THAT THE TRACK IS CLEAN AND TO PREVENT FUTURE DELAYS IN PROCESSING SAMPLES. THE SYSTEM IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    TREATMENT OF A CRITICALLY ILL PT WAS DELAYED DUE TO AN UNK LOCATION OF A SAMPLE ON THE ADVIA LABCELL TRACK. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PT INTERVENTION DUE TO THE DELAYED PT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA LABCELL LAB AUTOMATION SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. LABCELL NA

    Patients

    Seq Age Sex Outcome Treatment
    1