BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ISOTON III DILUENT

    MDR report key: 3775528 · Received April 28, 2014

    Report

    Report Number
    1061932-2014-00900
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GIF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON ROOT CAUSE, THE SUSPECT PRODUCT WAS IDENTIFIED TO BE THE REAGENT(S) USED WITH THE INSTRUMENT. THE FIRST PRODUCT IS LISTED 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. THE MANUFACTURING SITE ADDRESS HAS BEEN UPDATED TO CORRELATE TO THE PRODUCT. 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. METHOD, RESULTS AND CONCLUSION CODES CHANGED BASED ON ROOT CAUSE; PATIENT AND PRODUCT CODES ADDED, AS THE FIELDS IN THE 3500A FORM HAVE BEEN UPDATED SINCE THE INITIAL REPORT. 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.

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE REPLACED THE WHITE BLOOD CELL (WBC) BATH TO RESOLVE THIS ISSUE. HE VERIFIED THE HEMOGLOBIN (HGB) ON THE ABII 5C CONTROL MATCHED THE ASSIGNED VALUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ONE LEVEL OF THEIR 5C QUALITY CONTROLS (ABII) RECOVERED OUT HIGH FOR HEMOGLOBIN (HGB) ONLY. THERE WAS NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255137 COULTER ISOTON III DILUENT COUNTER, BLOOD CELL GIF BECKMAN COULTER NA 50793F

    Patients

    Seq Age Sex Outcome Treatment
    1