BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM PREMIER 5000

    MDR report key: 7799187 · Received August 20, 2018

    Report

    Report Number
    1217183-2018-00008
    Event Type
    Injury
    Date Received
    August 20, 2018
    Date of Event
    July 27, 2018
    Report Date
    August 20, 2018
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    CHL
    UDI-DI
    08426950870227
    PMA / PMN Number
    K173403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS INSUFFICIENT EVIDENCE PROVIDED TO INVESTIGATE THIS COMPLAINT. THE COPYILDATA FROM THE CUSTOMER'S GEM PREMIER 5000 WAS REVIEWED BUT WAS NOT FROM THE DATE OF THE EVENT. AN INTERNAL TEST WAS UNABLE TO REPRODUCE THE EVENT. THERE WAS NO MALFUNCTION IDENTIFIED AND THEREFORE, NO REMEDIAL ACTION INDICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SAMPLE WAS ANALYZED ON A PATIENT AND THE INCORRECT PATIENT IDENTIFIER WAS ENTERED. HOWEVER, ON NOTICING THIS INCIDENT, THE POCT LOOKED IN THE RESULTS ON THE LIS AND NOTICED THAT THE RESULTS HAD TRANSFERRED TO THE LIS (APEX) UNDER THE CORRECT PATIENT IDENTIFIER AND NOT TO THE INCORRECT PATIENT IDENTIFIER. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641162 GEM PREMIER 5000 CLINICAL CHEMISTRY INSTRUMENT CHL INSTRUMENTATION LABORATORY 00024019255 08426950870227

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other