BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ISOTON III DILUENT

    MDR report key: 3785640 · Received May 1, 2014

    Report

    Report Number
    1061932-2014-00962
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GIF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE CONFIRMED THERE WAS A BUILDUP OF FILM IN THE WBC BATH AND ON THE HGB LAMP. THE FSE REPLACED THE WBC BATH AND HGB LAMP RESOLVING THE ISSUE. (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON ROOT CAUSE, THE SUSPECT PRODUCT WAS IDENTIFIED TO BE THE REAGENT(S) USED WITH THE INSTRUMENT. SUBSEQUENT PRODUCTS ARE PROVIDED HERE; IT IS UNKNOWN WHICH LOTS WERE IN USE AT THE TIME OF THE EVENT. THEREFORE, EXPIRATION DATE AND DEVICE MANUFACTURING DATE ARE ALSO UNKNOWN FOR THIS EVENT. BRAND NAME: COULTER ISOTON III DILUENT; CATALOG #: 8546733; LOT #: 50793F THROUGH 50818F, BRAND NAME: COULTER ISOTON 4 DILUENT; CATALOG #: 8547148; LOT #: 18206F, BRAND NAME: COULTER LH SERIES DILUENT; CATALOG #: 8547194; LOT #: 510409F THROUGH 510657F AND M405237 THROUGH M503553. NEW INFORMATION ABOUT THE ROOT CAUSE WAS COMPLETED ON 8/12/2015. ROOT CAUSE CHANGED THE 510K FROM K010765 TO EXEMPT TO CORRELATE TO THE PRODUCT IN SECTION D. A RECALL WAS COMPLETED AND AN IMPORTANT PRODUCT NOTICE LETTER WAS SENT TO CUSTOMERS ON 09/09/2015. THE ROOT CAUSE HAS BEEN IDENTIFIED AS LOT TO LOT VARIATION IN THE SODIUM SULFATE USED IN THE REAGENT, WHICH RESULTED IN A COMPROMISED WHITE BLOOD CELL (WBC) BATH IN THIS EVENT. IN ADDITION, THE INVESTIGATION FOUND THAT THE ROOT CAUSE IDENTIFIED WOULD NOT CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH AS THE PROBABILITY OF HARM PER THE RISK ASSESSMENT IS HIGHLY UNLIKELY AND NOT A REPORTABLE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE HEMOGLOBIN (HGB) BACKGROUND WAS FAILING IN THE HMX AL ANALYZER. THE CUSTOMER ALSO REPORTED THE INSTRUMENT WAS LOCKING UP. THE ISSUE OCCURRED ON BACKGROUND COUNTS ONLY; THE CUSTOMER DID NOT REPORT PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262815 COULTER ISOTON III DILUENT COUNTER, BLOOD CELL GIF BECKMAN COULTER NA 50793F

    Patients

    Seq Age Sex Outcome Treatment
    1