BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABL80 FLEX CO-OX ANALYZER

    MDR report key: 2582807 · Received May 16, 2012

    Report

    Report Number
    2027541-2012-00032
    Event Type
    Other
    Date Received
    May 16, 2012
    Date of Event
    January 24, 2012
    Report Date
    April 11, 2012
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    PMA / PMN Number
    K080370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT WAS INCLUDED IN A ROUTINE GROUP OF SENSOR CASSETTE REPORTS BY THE DISTRIBUTOR. UPON REVIEW OF THESE REPORTS IT WAS RECOGNIZED THAT THE REPORTED PATIENT RESULT FOR GLUCOSE WAS BEING QUESTIONED BY THE USER. DATA LOGS WERE OBTAINED FROM THE ANALYZER AND REVIEWED. THE CALIBRATION AND QUALITY CONTROL RECORDS FOR THIS ANALYZER DEMONSTRATE PROPER FUNCTION. THE SENSOR CASSETTE, USED DURING THE SUBJECT SAMPLE MEASUREMENT, WAS RETURNED FOR INVESTIGATION. FAILURE INVESTIGATION RESULTS ON THE RETURNED SENSOR CASSETTE DEMONSTRATED PROPER FUNCTION WITHIN MANUFACTURING SPECIFICATIONS. THIS TESTING INCLUDED A VERIFICATION OF A KNOWN PO2 DEPENDENCE ON THE GLUCOSE SENSOR WHICH IS DOCUMENTED IN THE ABL80 FLEX REFERENCE MANUAL AND IS CONSISTENT WITH THIS REPORTED EXPERIENCE OF A HIGH GLUCOSE LEVEL IN COMBINATION WITH A VERY LOW OXYGEN LEVEL.

    Description of Event or Problem · 1

    A ROUTINE REPORT FROM OUR DISTRIBUTOR IN (B)(6), INCLUDED A PATIENT SAMPLE PRINTOUT WITH A GLUCOSE VALUE OF 29 MG/DL AND A PO2 VALUE OF 31 MMHG. ACCORDING TO THE CUSTOMER, THE GLUCOSE VALUE MEASURED IN THE LAB WAS APPROXIMATELY 400 MG/DL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1