BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABL80 FLEX CO-OX ANALYZER

    MDR report key: 1600905 · Received February 11, 2010

    Report

    Report Number
    2027541-2010-00002
    Event Type
    Injury
    Date Received
    February 11, 2010
    Date of Event
    January 15, 2010
    Report Date
    January 18, 2010
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    PMA / PMN Number
    K080370
    Removal / Correction Number
    2027541-01/02/10-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION REVEALED THAT THE CAUSE WAS THE RESULT OF A SOFTWARE ANOMALY. THE SOFTWARE MAKES AN INCORRECT ASSUMPTION THAT CO-OX ANALYSIS DOES NOT HAVE TO RUN UNLESS CTHB IS A REPORTABLE PARAMETER. INVESTIGATIONS HAVE REVEALED THAT IF, DURING PATIENT'S SAMPLE MEASUREMENT, THE TOTAL HEMOGLOBIN (THB) PARAMETER IS NOT SELECTED FOR REPORTING THEN ANY RESULTS REPORTED FOR THE FRACTIONAL HEMOGLOBIN PARAMETERS (SO2, FO2HB, FCOHB, FMETHB AND FHHB) WILL BE VALUES TAKEN FROM A PRIOR MEASUREMENT AND NOT ASSOCIATED WITH THE CURRENT PATIENT'S MEASUREMENT. THIS PRIOR MEASUREMENT MAY BE FROM ANOTHER PATIENT'S SAMPLE OR A QUALITY CONTROL SAMPLE DEPENDING ON WHAT TYPE OF MEASUREMENT WAS PERFORMED BY THE SYSTEM IMMEDIATELY PRIOR TO THE PATIENT'S SAMPLE IN QUESTION. THE CORRECTIVE ACTION WAS A SOFTWARE MODIFICATION TO RESOLVE THE ISSUE WHICH WILL BE PROVIDED TO USERS THROUGH A MANDATORY SOFTWARE UPGRADE. AFFECTED UNITS WILL BE UPGRADED TO SOFTWARE (B) (4). A RECALL NUMBER HAS NOT YET BEEN ASSIGNED BY FDA. THE NUMBER DOCUMENTED BY (B) (4) IN THE RECALL NOTIFICATION TO FDA IS (B) (4).

    Description of Event or Problem · 1

    ON 1/18/10, A DISTRIBUTOR REPORTED A PROBLEM WHERE THEY WERE EXPERIENCING TOO MANY INCONSISTENCIES TO REPORT OUT PATIENT RESULTS FROM AN ABL80 FLEX CO-OX ANALYZER. BASED ON RESULTS FROM THE ABL80 FLEX CO-OX, PATIENTS WERE TREATED FOR CO POISONING WITH HYPERBARIC OXYGEN.

    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 Required Intervention