BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRMA TRUPOINT BLOOD ANALYZER

    MDR report key: 6614289 · Received June 6, 2017

    Report

    Report Number
    2183953-2016-00001
    Event Type
    Malfunction
    Date Received
    June 6, 2017
    Date of Event
    May 31, 2016
    Report Date
    July 6, 2016
    Manufacturer
    LIFEHEALTH, LLC
    Product Code
    CHL
    PMA / PMN Number
    K945240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER WAS RUNNING A BLOOD GAS TEST. THE ANALYZER ALLOWS YOU TO ENTER THE PATIENT'S TEMPERATURE AND USES THE TEMPERATURE TO GIVE A TEMPERATURE CORRECTED RESULT ALONG WITH TEH UNCORRECTED RESULT. IF NO TEMPERATURE IS ENTERED, THE DEFAULT IS 37C. THE USER DID NOT ENTER A TEMPEARTURE BUT WHEN THE RESULTS PRINTED, THERE WAS BOTH A UNCORRECTED (37C) RESULT AND A CORRECTED RESULT TO A PATIENT TEMPERATURE OF 0C. THE USER DID NOT ENTER ANY PATIENT TEMPERATURE SO IT SHOULD HAVE ONLY REPORTED THE UNCORRECTED, 37C RESULT. ALSO THE ANALYZER ONLY ALLOWS THE USER TO ENTER PATIENT TEMPERATURES BETWEEN 15-45C, SO IF THEY HAD TRIED TO ENTER A TEMPERATURE OF 0C, THEY WOULD HAVE RECEIVED AN ERROR MESSAGE. THE USER DID NOT REPORT EITHER RESULT AND HAD A BACK UP ANALYZER TO USE. WHEN THE ANALYZER CAME IN FOR INVESTIGATION, WE COULD NOT REPRODUCE THE ERROR. THERE WERE ALSO MISSING TEST RECORDS. TEST NUMBERS ARE LOGGED SEQUENTIALLY. THE ERRONEOUS RESULT WAS TEST 9367 AND TEST 9365 WAS MISSING AS IF THE TEST NEVER HAPPENED. THERE WERE EQC TESTS MISSING FOR THAT DAY ((B)(6) 2016).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396921 IRMA TRUPOINT BLOOD ANALYZER BLOOD GAS ANALYZER CHL LIFEHEALTH, LLC IRMA TRUPOINT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other