BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL80 FLEX CO-OX ANALYZER

    MDR report key: 1578933 · Received January 4, 2010

    Report

    Report Number
    2027541-2010-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2010
    Date of Event
    November 13, 2009
    Report Date
    November 13, 2009
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    PMA / PMN Number
    K080370
    Removal / Correction Number
    2027541-12/31/09-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION RECEIVED (B)(6) 2009 AND FURTHER INVESTIGATION, IT WAS REVEALED THAT THE CAUSE FOR THIS INCIDENT 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 SAMPLE MEASUREMENT, THE TOTAL HEMOGLOBIN (THB) PARAMETER IS NOT SELECTED FOR REPORTING THEN ANY RESULTS REPORTED FOR THE FRACTIONAL HEMOGLOBIN PARAMETERS (SO2, F02HB, FCOHB, FMETHB AND FHHB) WILL BE VALUES TAKEN FROM A PRIOR MEASUREMENT AND NOT ASSOCIATED WITH THE CURRENT PATIENT MEASUREMENT. THIS PRIOR MEASUREMENT MAY BE FROM ANOTHER PATIENT SAMPLE OR A QUALITY CONTROL SAMPLE DEPENDING ON WHAT TYPE OF MEASUREMENT WAS PERFORMED BY THE SYSTEM IMMEDIATELY PRIOR TO THE PATIENT 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 VERSION 1.35. A RECALL NUMBER HAS NOT YET BEEN ASSIGNED BY FDA. THE NUMBER DOCUMENTED BY SENDX IN THE RECALL NOTIFICATION TO FDA IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009, A DISTRIBUTOR REPORTED A PROBLEM WHERE THE ANALYZER REPORTS HIGH COHB RESULTS ON NORMAL BLOOD SAMPLES WHEN THEY RUN A "CO-OX ONLY" PANEL.

    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