BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL80 FLEX CO-OX ANALYZER

    MDR report key: 2080939 · Received April 13, 2011

    Report

    Report Number
    2027541-2011-00001
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 18, 2011
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    PMA / PMN Number
    K080370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS TAKEN OUT OF CLINICAL USE ON (B)(6) 2011 WHILE IT IS BEING INVESTIGATED BY THE LOCAL SERVICE REP. DATA LOGS WERE OBTAINED FROM THE ANALYZER, AND HAVE BEEN INVESTIGATED. THE SENSOR CASSETTE USED (SC S/N (B)(4) LOT 55708) WAS RETURNED ON 3-3-2011, AND INITIAL ANALYSIS SHOWED NOTHING UNUSUAL. THE SC IS NOW BEING ANALYZED BY R & D. THE ANALYZER DID NOT ISSUE ANY WARNINGS FOR THE ERRONEOUS PARAMETERS, AS CALIBRATIONS AND QC'S ALL PASSED. THE ERROR WAS SPORADIC, AND SEEMED TO OCCUR IMMEDIATELY AFTER SOME PLASMA SAMPLES WERE ANALYZED. THE PLASMA SAMPLES ARE CURRENTLY SUSPECTED TO HAVE CAUSED THE ERROR, AND HAVE THUS BEEN SUBJECT OF INVESTIGATION. THE ERROR APPEARED TO NORMALIZE IN SUBSEQUENT ANALYSIS. OPERATOR'S MANUAL RECOMMENDS ONLY WHOLE BLOOD TO BE USED WITH ANALYZER. USING PLASMA SAMPLES IS A USER ERROR.

    Description of Event or Problem · 1

    A DR IN THE DEPT THOUGHT THE TEST RESULTS FROM ABL80 COOX WERE INCONSISTENT WITH THE PT'S STATUS. THE DR ALSO ANALYZED A SAMPLE OF BLOOD FROM HIMSELF, WHICH CONFIRMED THAT THE TEST RESULTS COULD NOT BE REAL. A HYPOPHYSECTOMISED PT THAT HAD BEEN OPERATED SPENT THE NIGHT AT AN ICU INSTEAD OF THE NORMAL UNIT AFTER SURGERY, BECAUSE OF RESULTS FROM THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABL80 FLEX CO-OX ANALYZER PH, BLOODGAS, ELECTROLYTE ANALYSIS SYSTEM CHL SENDX MEDICAL, INC. 393-841

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR