BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABL80 FLEX CO-OX ANALYZER

    MDR report key: 2428876 · Received January 21, 2012

    Report

    Report Number
    2027541-2012-00003
    Event Type
    Other
    Date Received
    January 21, 2012
    Date of Event
    October 27, 2011
    Report Date
    November 15, 2011
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    PMA / PMN Number
    K080370
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA LOGS WERE OBTAINED FROM THE ANALYZER, AND HAVE BEEN INVESTIGATED. THE CALIBRATION AND QUALITY CONTROL RECORDS FOR THIS ANALYZER DEMONSTRATE THE ANALYZER TO BE PERFORMING PROPERLY. THE PT SAMPLE WITH A GLUCOSE MEASURED VALUE OF 5.2 MMOL/L ALSO HAD AN OXYGEN VALUE OF 15 MMHG. THE ABL80 REFERENCE MANUAL PROVIDES PERFORMANCE SPECIFICATIONS FOR THE MEASUREMENT OF GLUCOSE. THE MANUAL DEFINES THE LIMITS OF GLUCOSE LINEARITY AS A FUNCTION OF THE AVAILABLE OXYGEN IN THE SAMPLE. THERE ARE NO LINEARITY CLAIMS WHEN THE OXYGEN LEVEL IS BELOW 20 MMHG.

    Description of Event or Problem · 1

    THE USER REPORTS THAT THE ABL80 RETURNED A GLUCOSE RESULT OF 5.2 MMOL/L. THE SAMPLE WAS RETESTED ON THE ABL80 AND THE GLUCOSE RESULT WAS 5.4 MMOL/L. THE ABL80 GLUCOSE RESULTS DID NOT FIT THE CLINICAL STATUS OF THE DIABETIC KETOACIDOSIS PT AND GLUCOSE RESULT FROM A GLUCOMETER. THE USER THEN SENT THE SAMPLE TO THE LABORATORY WHICH REGISTERED A GLUCOSE RESULT OF 54.8 MMOL/L. THERE IS NO PT HARM REPORTED.

    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