BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI

    MDR report key: 4906581 · Received July 10, 2015

    Report

    Report Number
    1823260-2015-03793
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 22, 2015
    Report Date
    August 4, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJC
    PMA / PMN Number
    K945915
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. A GENERAL INSTRUMENT RELATED ISSUE CAN BE EXCLUDED. A POTENTIAL SAMPLE RELATED ISSUE WAS IDENTIFIED. THE NURSE DID NOT MIX THE SAMPLE AGAIN BEFORE IT WAS ANALYZED. THE ROOT CAUSE MAY BE RELATED TO A PRE-ANALYTIC ISSUE SUCH AS SEDIMENTATION.

    Description of Event or Problem · 1

    A NURSE AT THE CUSTOMER SITE COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR THB AND HCT ON THE B221 ANALYZER LOCATED IN THE INTENSIVE CARE UNIT (ICU). THE INITIAL THB RESULT WAS 15.6 G/DL. THE REPEAT THB RESULT 5 MINUTES LATER WAS 8.4 G/DL. THE INITIAL HCT RESULT 42.7%. THE REPEAT HCT RESULT 5 MINUTES LATER WAS 19.0%. A COMPLETE BLOOD COUNT (CBC) WAS RUN AT THIS TIME AND THE THB RESULT WAS 9.5 G/DL AND THE HCT RESULT WAS 27.6%. NO ADVERSE EVENT WAS REPORTED. THE PATIENT HAS BEEN MOVED OUT OF THE ICU. QUALITY CONTROLS WERE ACCEPTABLE. THE CUSTOMER MONITORED SAMPLES BEING MEASURED ON THE ANALYZER THE DAY AFTER THE EVENT AND NO ABNORMAL RESULTS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448950 OMNI BLOOD GAS ANALYZER JJC ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 081 YR