BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ISOTON III DILUENT

    MDR report key: 3704630 · Received March 27, 2014

    Report

    Report Number
    1061932-2014-00684
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND CONFIRMED THE HEMOGLOBIN (HGB) BACKGROUND WOULD ONLY RECOVER HIGH WHEN PERFORMING A "REPEAT BACKGROUND TEST" OR "SYSTEM TEST". THE FSE DETERMINED THE WHITE BLOOD CELL (WBC) BATH HOUSING IN THE HGB READ AREA WAS DISCOLORED. THE FSE REPLACED THE WBC BATH HOUSING RESOLVING THE HIGH HGB BACKGROUND COUNTS AND VOLTAGE ERRORS. (B)(4).

    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. 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 HEMOGLOBIN (HGB) BACKGROUND WAS RECOVERING HIGH WHEN USING THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE INSTRUMENT GENERATED VOLTAGE (VDC - VOLTS DIRECT CURRENT) ERRORS. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO THE USER OR PATIENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180731 COULTER ISOTON III DILUENT COUNTER, BLOOD CELL GIF BECKMAN COULTER NA 50793F

    Patients

    Seq Age Sex Outcome Treatment
    1