BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABL80 FLEX CO-OX ANALYZER

    MDR report key: 2428877 · Received January 21, 2012

    Report

    Report Number
    2027541-2012-00002
    Event Type
    Other
    Date Received
    January 21, 2012
    Date of Event
    December 21, 2011
    Report Date
    December 22, 2011
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    PMA / PMN Number
    K080370
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS TAKEN OUT OF CLINICAL USE ON (B)(4) 2011. 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 6.2 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

    A DOCTOR FROM (B)(6) THOUGHT, THE TEST RESULTS FROM ABL80 COOX WERE INCONSISTENT FOR A DIABETIC KETOACIDOSIS PT. THE USER REPORTS THAT THE ABL80 RETURNED A GLUCOSE RESULT OF 6.2 MMOL/L AND A LAB INSTRUMENT RETURNED A RESULT OF 52.6 MMOL/L. AFTER INSULIN TREATMENT, THE PT GLUCOSE LEVEL DROPPED TO 36.2 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