BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARVEST ( LIS)

    MDR report key: 2559523 · Received May 4, 2012

    Report

    Report Number
    2432235-2012-00142
    Event Type
    Malfunction
    Date Received
    May 4, 2012
    Date of Event
    April 11, 2012
    Report Date
    April 12, 2012
    Manufacturer
    ORCHARD SOFTWARE CORPORATION
    Product Code
    GKL
    PMA / PMN Number
    K971998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER ANALYZING THE INSTRUMENT DATA, THE SIEMENS FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. THE MISMATCH OF THE PATIENTS ID ON THE RUN SCREEN REPORT WAS CAUSED BY THE LIS SENDING PATIENT ID'S THAT EXCEEDS 14 CHARACTERS AS REQUIRED BY THE PRODUCT LABELING INSTRUCTIONS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    TWO PATIENT SAMPLES FROM THE SAMPLE RACK WERE RUN ON THE ADVIA 120 ANALYZER. THE OPERATOR STATED THAT THE SID AND THE PATIENT NAME MATCHED CORRECTLY IN THEIR LABORATORY INFORMATION SYSTEM (LIS) BUT WAS DIFFERENT ON THE ADVIA 120 ANALYZER RUNSCREEN. THE PATIENT NAMES ON THE RUNSCREEN WERE SUPPLIED FROM THE FACILITY'S LIS. THE OPERATOR NOTICED THE MISMATCH WITH THE PATIENTS NAME AND DID NOT REPEAT THE SAMPLES BUT INSTEAD MATCHED THE SAMPLES BY THE POSITION ON THE RACK AND RUNSCREEN WITH SID AND PATIENT NAME FROM THE LIS SYSTEM. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE SYSTEM BARCODE READER HAVING MISREAD THE SAMPLE BARCODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARVEST ( LIS) ORCHARD SOFTWARE CORPORATION, PRODUCT CODE: GKL GKL ORCHARD SOFTWARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1