BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABL80 FLEX CO-OX ANALYZER

    MDR report key: 2602523 · Received May 30, 2012

    Report

    Report Number
    2027541-2012-00033
    Event Type
    Other
    Date Received
    May 30, 2012
    Report Date
    May 4, 2012
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    PMA / PMN Number
    K080370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH THE ANALYZER WAS NOT RETURNED FOR FAILURE INVESTIGATION, LOGS FROM THE ANALYZER WERE PROVIDED. ANALYZER LOGS INCLUDED PT, QUALITY CONTROL AND CALIBRATION LOGS. QUALITY CONTROL AND CALIBRATION LOGS DOCUMENTED A WELL-FUNCTIONING ANALYZER WITH MFR'S SPECIFICATIONS. A SET OF CONSUMABLE ITEMS WAS RETURNED BY THE CUSTOMER, BUT THESE ITEMS WERE NOT THE ONES IN USE AT THE TIME OF THE PT ANALYSIS IN QUESTION (THE CONSUMABLE ITEMS IN USE AT THE TIME WERE NOT AVAILABLE TO INVESTIGATION). THE RETURNED ITEMS WERE TESTED AND DEMONSTRATED SUCCESSFUL CALIBRATION AND QUALITY CONTROL RESULTS WITHIN MFR'S SPECIFICATIONS. AS THE DEFICIENCY EXPRESSED BY THE CUSTOMER RESEMBLES THAT OF A PREVIOUSLY REPORTED MDR, THIS EVENT WILL BE REPORTED AS AN MDR ACCORDING TO THE 2-YEAR ASSUMPTION RULE EVEN THOUGH NO EVIDENCE OF A MALFUNCTION COULD BE ESTABLISHED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A PO2 RESULT FROM AN ABL80 FLEX CO-OX ANALYZER THAT DID NOT MATCH THE CLINICAL STATE OF THE PT. THE PO2 FROM THE ABL80 FLEX CO-OX ANALYZER WAS LOWER THAN THE VALUE EXPECTED BY THE HEALTHCARE PROFESSIONAL. THE USER WAS NOT, HOWEVER, ABLE TO PROVIDE THE DATE AND TIME NOR THE SPECIFIC MEASURED VALUES FOR THE SAMPLE IN QUESTION. THE CUSTOMER STATED THAT THE PT WAS NOT MANAGED OR TREATED BASED ON THE RESULTS FROM THE ABL80 FLEX CO-OX ANALYZER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1