BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM PREMIER 4000

    MDR report key: 7650838 · Received June 29, 2018

    Report

    Report Number
    1217183-2018-00004
    Event Type
    Injury
    Date Received
    June 29, 2018
    Date of Event
    May 29, 2018
    Report Date
    June 29, 2018
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    CHL
    UDI-DI
    08426950452591
    PMA / PMN Number
    K133407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA REVIEW SHOWED THAT RESPONSE FROM THE CUSTOMER'S LIS FOR QUERIES OF THE TWO MRN'S WAS "PATIENT HAS NOT BEEN FOUND". THIS IS CONSISTENT WITH THE DESCRIPTION IN THE COMPLAINT SINCE PATIENT DEMOGRAPHICS WERE NOT DISPLAYED ON THE ANALYZER SCREEN AFTER THE MRN WAS ENTERED. THE GEM PREMIER 4000 WERE PREFORMING TO SPECIFICATION, AND NO MALFUNCTION WAS IDENTIFIED. THE OPERATOR ENTERED THE MEDICAL RECORD NUMBER, PATIENT LAST NAME AND FIRST NAME MANUALLY, WHICH RESULTED IN A TRANSCRIPTION ERROR OF THE MRN'S. THERE WAS NO PATIENT IMPACT. THE OPERATOR WAS RE-EDUCATED ON THE PROCESS TO VERIFY PATIENT IDENTIFIERS. CUSTOMER SITE HAS APPLIED THE CORRECT RESULTS TO THE PATIENTS. THE CONNECTION ISSUE APPEARS TO BE RELATED TO THE HOSPITAL'S LIS. NO REMEDIAL ACTION REQUIRED.

    Description of Event or Problem · 1

    COMPLAINT STATED THAT THERE WERE TWO SETS OF BLOOD GAS SAMPLES ANALYZED ON GEM PREMIER 4000 SN (B)(4). THE OPERATOR ENTERED THE PATIENTS' FIRST AND LAST NAMES CORRECTLY INTO THE GEM BUT INCORRECTLY ENTERED THE MRNS (MEDICAL RECORD NUMBERS) . THE PRINTOUTS SHOW THE CORRECT PATIENT NAMES AND RESULTS AND THE INCORRECT MRNS. THE RESULTS WENT TO THE INCORRECT PATIENT EMR (ELECTRONIC MEDICAL RECORD). THERE WAS NO PATIENT IMPACT. THE RESULTS WERE CORRECTLY APPLIED TO THE CORRECT EMR AND REMOVED FROM THE INCORRECT EMR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492894 GEM PREMIER 4000 CLINICAL CHEMISTRY INSTRUMENT CHL INSTRUMENTATION LABORATORY 2261 08426950452591

    Patients

    Seq Age Sex Outcome Treatment
    1